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CompletedNCT03266016REDventUpdated Sep 17, 2025Results posted

Real-time Effort Driven VENTilator Management

An interventional study of Computerized Ventilator Protocol and Esophageal Manometry in Ventilation Therapy; Complications, Diaphragm Disease and Pediatric Respiratory Diseases, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to participants aged 30 Days to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
30 Days to 18 Years
Sex
All
01

Study summary

This study is a Phase II controlled clinical trial that will obtain comprehensive, serial assessments of respiratory muscle strength and architecture to understand the evolution of ventilator-induced respiratory muscle weakness in critically ill children, and test whether a novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can preserve respiratory muscle strength and reduce time on MV. REDvent offers systematic recommendations to reduce controlled ventilation during the acute phase of MV, and uses real-time measures from esophageal manometry to adjust supported ventilator pressures such that patient effort of breathing remains in a normal range during the ventilator weaning phase. This phase II clinical trial is expected to enroll 276 children with pulmonary parenchymal disease, anticipated to be ventilated > 48 hrs. Patients will be randomized to REDvent-acute vs. usual care for the acute phase of MV (interval from intubation to first spontaneous breathing trial (SBT)). Patients in either group who fail their first Spontaneous Breathing Trial (SBT), will also be randomized to REDvent-weaning vs. usual care for the weaning phase of MV (interval from first SBT to passing SBT). The primary clinical outcome is length of weaning (time from first SBT until successful passage of an SBT or extubation (whichever comes first)). Mechanistic outcomes surround multi-modal serial measures of respiratory muscle capacity (PiMax), load (resistance, compliance), effort (esophageal manometry), and architecture (ultrasound) throughout the course of MV. Upon completion, this study will provide important information on the pathogenesis and timing of respiratory muscle weakness during MV in children and whether this weakness can be mitigated by promoting more normal patient effort during MV via the use of REDvent. This will form the basis for a larger, Phase III multi-center study, powered for key clinical outcomes such as 28-day Ventilator Free Days.

Read the detailed description

Study Aims:

SA1: To determine if REDvent acute and/or weaning phase protocols can shorten the duration of weaning from MV (Primary outcome).

SA2: To determine if changes to direct measures of respiratory muscle strength, load, effort, and architecture throughout the duration of MV are related to weaning outcomes.

SA3: To determine if patient effort of breathing during both acute and weaning phases of MV is independently associated with the development of respiratory muscle weakness.

Study Design: Single-center randomized controlled trial (138 children per arm) using REDvent (intervention arm) as compared with usual care ventilator management including a standardized daily SBT (control arm). Acute phase randomization will occur upon study enrollment, and patients who fail the first SBT will undergo a weaning phase randomization. The investigators will obtain serial measurements of respiratory system capacity, load, effort of breathing, and diaphragm architecture throughout the course of MV.

Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 > 90%), and undergoes a Spontaneous Breathing Trial (SBT).

  1. Intervention Arm (REDvent-acute): Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
  2. Control Arm (Control-acute): Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.

Weaning Phase: The weaning phase is defined as the time from the first Spontaneous Breathing Trial (SBT) until the patient successfully passes an SBT or is extubated (whichever comes first). Patients who pass the initial SBT at the end of the acute phase will not undergo weaning phase randomization.

  1. Intervention Arm (REDvent-weaning): Patients will be managed in a pressure support/CPAP mode of ventilation with assessments or changes to the level of pressure support every 4 hours, targeting maintaining effort of breathing (esophageal manometry) in a normal range. An SBT will be conducted daily, and the weaning phase will continue until the patient passes the SBT.
  2. Control Arm (Control-weaning): Ventilator management will be per usual care. An SBT will be conducted daily, and the weaning phase will continue until the patient passes the SBT.

Analysis Plan and Sample Size Justification:

Aim 1: The primary outcome is weaning duration. Sample size has been determined to adequately power 3 separate comparative analyses: (a) REDvent-acute versus Acute Phase control (b) REDvent-weaning phase versus Weaning Phase control (c) REDvent both phases versus control both phases. Power is based on 2 planned methods for analysis: cox proportional hazard ratios for multivariable analysis and univariate analysis with an independent t-test using log transformation (as needed) to account for the expected distribution of weaning duration. For all three of the planned comparisons above, with the proposed sample size the investigators would be adequately powered (>0.8) to detect a difference in weaning duration of ≥ 1 day, or a hazard ratio of ≥ 1.4 between groups. The secondary outcomes are ventilator free days and extubation failure. Directly comparing control only patients to REDvent only patients, with an expected standard deviation for VFDs between 5 to 9 days, the investigators will be able to detect a 2-day change in VFDs between groups with a power between 0.35 and 0.82. Re-intubation rates are expected to be 10%, allowing the investigators to confirm that REDvent is not inferior to usual care in regards to re-intubation with a non-inferiority margin of 0.10 with a power of 0.8 and alpha of 0.05.

Aim 2: The primary outcome of this aim is weaning duration. For respiratory muscle strength the investigators will compare the first measured aPiMax (after resolution of the acute phase, before the first SBT), the trajectory and value of the daily aPiMax during the weaning phase prior to extubation, the lowest and highest measured aPiMax, and aPiMax on the day of extubation against weaning duration. For analysis, aPiMax will be dichotomized at 30 cmH2O, and weaning duration will be compared between patients with aPiMax > 30 versus ≤ 30 cmH2O using a t-test with or without log-transformation, or Mann-Whitney U test, depending on the distribution. From preliminary data, it is anticipated at least 35% of patients (n=84) will have aPiMax ≤ 30 cmH2O. Based on a similar power analysis as presented above, this would allow the investigators to determine whether low aPiMax is associated with a ≥ 1-day increase in weaning duration, with an alpha of 0.05 and power of 0.8. The investigators will perform identical analysis for ePiMax. Diaphragm Thickness analysis will compound daily ultrasound measures to detect the relative change in diaphragm thickness from study day 1 until passage of an SBT. The investigators will compare the change in thickness after resolution of the acute phase (on the day of the first SBT) against weaning duration, in a similar manner as proposed above for aPiMax. In addition to weaning duration, the investigators will also examine whether the respiratory measures taken just prior to or during each SBT are associated with the patient passing the SBT. For example with aPiMax and ePiMax, the investigators will examine if there is a dose response relationship between PiMax measured just before the SBT and the rate of passage of the subsequent SBT.

Aim 3: The primary outcome of this aim is aPiMax \< 30 cmH2O.The analysis will focus on determining whether the degree of patient effort of breathing is independently associated with the development of respiratory muscle weakness. For the acute phase, the investigators will generate a time-weighted average PRP during the acute phase and graph it against aPiMax at the first SBT. They will subsequently dichotomize aPiMax at the first SBT and compare mean time weighted average PRP in the acute phase between aPiMax groups (> 30 vs. ≤ 30 cmH2O). For the weaning phase, the investigators will graph the changes in aPiMax throughout the weaning phase (from first failed SBT until successful SBT) against time-weighted average PRP, with the anticipation that low PRP will be associated with either further reductions in aPiMax, or no improvement, while PRP in the physiologic range of 150-400 will be associated with improvement in aPiMax. The investigators will subsequently dichotomize aPiMax (at 30 cm H2O) at the time of successful passage of an SBT and compare time-weighted average PRP in the weaning phase between aPiMax groups. Subsequently, the investigators will build a multivariable logistic regression model on the outcome of aPiMax ≤ 30 cmH2O to determine if time-weighted PRP in the acute phase, weaning phase or both have an independent association with preserving aPiMax, after controlling for confounding variables.

02

Conditions studied

  • Ventilation Therapy; Complications
  • Diaphragm Disease
  • Pediatric Respiratory Diseases
03

Who can participate

Ages eligible
30 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children > 1 month (>44 weeks CGA) and ≤ 18 years of age AND
  • Supported on mechanical ventilation with pulmonary parenchymal disease (i.e., pneumonia, bronchiolitis, Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5 or Oxygenation Index (OI) ≥) AND
  • Who are within 48 hours of initiation of invasive mechanical ventilation (allow for up to 72 hours for those transferred from another institution)

Exclusion criteria

Exclusion Criteria:

  • Contraindications to use of an esophageal catheter (i.e. severe mucosal bleeding, nasal encephalocele, transphenoidal surgery) OR
  • Contraindications to use of RIP bands (i.e. omphalocele, chest immobilizer or cast) OR
  • Conditions precluding diaphragm ultrasound measurement (i.e. abdominal wall defects, pregnancy) OR
  • Conditions on enrollment that preclude conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, critical airway, intracranial hypertension, Extra Corporeal Life Support (ECLS), intubation for UAO, DNR, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR
  • Primary Attending physician refuses (will be cleared with primary attending before approaching the patient).
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
248 participants (actual)

Study arms

  • Experimental
    REDvent-acute

    Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.

    Other: Computerized Ventilator Protocol · Diagnostic Test: Esophageal Manometry · Diagnostic Test: Respiratory Inductance Plethysmography (RIP) · Diagnostic Test: Diaphragm Ultrasound · Diagnostic Test: Maximal Inspiratory Pressure

  • Placebo comparator
    Control-acute

    Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.

    Diagnostic Test: Esophageal Manometry · Diagnostic Test: Respiratory Inductance Plethysmography (RIP) · Diagnostic Test: Diaphragm Ultrasound · Diagnostic Test: Maximal Inspiratory Pressure

  • Experimental
    REDvent-weaning

    Weaning Phase: The weaning phase is defined as the time from the first Spontaneous Breathing Trial (SBT) until the patient successfully passes an SBT or is extubated (whichever comes first). Patients who pass the initial SBT at the end of the acute phase will not undergo weaning phase randomization. Patients will be managed in a pressure support/CPAP mode of ventilation with assessments or changes to the level of pressure support every 4 hours, targeting maintaining effort of breathing (esophageal manometry) in a normal range. An SBT will be conducted daily, and the weaning phase will continue until the patient passes the SBT.

    Other: Computerized Ventilator Protocol · Diagnostic Test: Esophageal Manometry · Diagnostic Test: Respiratory Inductance Plethysmography (RIP) · Diagnostic Test: Diaphragm Ultrasound · Diagnostic Test: Maximal Inspiratory Pressure

  • Placebo comparator
    Control-weaning

    Weaning Phase: The weaning phase is defined as the time from the first Spontaneous Breathing Trial (SBT) until the patient successfully passes an SBT or is extubated (whichever comes first). Patients who pass the initial SBT at the end of the acute phase will not undergo weaning phase randomization. Ventilator management will be per usual care. An SBT will be conducted daily, and the weaning phase will continue until the patient passes the SBT.

    Diagnostic Test: Esophageal Manometry · Diagnostic Test: Respiratory Inductance Plethysmography (RIP) · Diagnostic Test: Diaphragm Ultrasound · Diagnostic Test: Maximal Inspiratory Pressure

Interventions

  • OtherComputerized Ventilator Protocol

    Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.

  • Diagnostic testEsophageal Manometry

    Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure

  • Diagnostic testRespiratory Inductance Plethysmography (RIP)

    RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials

  • Diagnostic testDiaphragm Ultrasound

    Daily measurement of diaphragm thickness and diaphragm contractile activity

  • Diagnostic testMaximal Inspiratory Pressure

    Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion

05

What researchers measure

Primary outcomes

  1. Median Duration of Weaning

    Time from first attempted SBT until SBT passage or extubation \[whichever comes first\]

    Time frame: First 28 days of Mechanical Ventilation

Secondary outcomes

  1. Median Ventilator Free Days Between Acute Phase Randomization Groups

    Days alive and not on mechanical ventilation

    Time frame: 28 days

  2. Number of Participants With Extubation Failure

    re-intubation

    Time frame: Within 48 hours of extubation, assessed through study completion up to maximum of 90 Days

  3. Number of Participants With Mortality

    Death

    Time frame: Through study completion up to maximum of 90 Days

  4. Median Maximal Inspiratory Airway Pressure During Airway Occlusion (aPiMax) at First Spontaneous Breathing Trial During Acute Phase.

    Measured during standardized airway occlusion maneuvers

    Time frame: Assessed on the day of first spontaneous breathing trial up to 28 days

  5. Median Maximal Inspiratory Esophageal Pressure During Airway Occlusion (ePiMax) During Acute Phase.

    Measured during standardized airway occlusion maneuvers

    Time frame: Assessed on the day of first spontaneous breathing trial up to 28 days

  6. Median Percentage Change in Diaphragm Thickness on Exhalation (Dte) From Baseline During Acute Phase

    From daily ultrasound measurement

    Time frame: Each day from study initiation until extubation up to a maximum of 28 days

06

Results

Posted Jul 11, 2025
Limitations and caveats
The structure of the trial was as described but the analytic approach was not to treat them as 4 different groups. All patients who were exposed to REDVent versus usual care during the acute phase were analyzed for outcomes attributed to the acute phase.

Participant flow

Acute Phase (0 to 28 Days)
Participant flow — Acute Phase (0 to 28 Days)
MilestoneAcute: REDventAcute: ControlWeaning: RedventWeaning: Control
Started12612200
Exited study at acute phase755600
Completed506600
Not completed765600
Withdrew: Withdrawal by subject1000
Withdrew: Completed study at acute phase.755600
Weaning Phase (0 to 28 Days)
Participant flow — Weaning Phase (0 to 28 Days)
MilestoneAcute: REDventAcute: ControlWeaning: RedventWeaning: Control
Started005858
Completed005858
Not completed0000

Outcome measures

PrimaryMedian Duration of Weaning

Time from first attempted SBT until SBT passage or extubation \[whichever comes first\]

Time frame:
First 28 days of Mechanical Ventilation
Reported as:
Median · days
Median Duration of Weaning
daysAcute: REDventAcute: Control
Acute0.09 (0.08 to 2.03)1.04 (0.08 to 2.17)
Weaning2.03 (1.09 to 3.58)2.10 (1.08 to 4.05)
Statistical analysis
  • Acute: REDvent vs Acute: Control · Proportional Odds Logistic Regression · p = .045 · Odds ratio (or): 1.67 · 95% CI 1.01 to 2.77
  • Acute: REDvent vs Acute: Control · Proportional odds logistic regression: 1.3 · 95% CI 0.7 to 2.6
SecondaryMedian Ventilator Free Days Between Acute Phase Randomization Groups

Days alive and not on mechanical ventilation

Time frame:
28 days
Reported as:
Median · days
Median Ventilator Free Days Between Acute Phase Randomization Groups
daysAcute: REDventAcute: Control
Median Ventilator Free Days Between Acute Phase Randomization Groups21.9 (14.0 to 24.5)21.3 (14.2 to 23.9)
Statistical analysis
  • Acute: REDvent vs Acute: Control · Incident rate ratio: 1.03 · 95% CI 0.84 to 1.25Negative binomial model.
SecondaryNumber of Participants With Extubation Failure

re-intubation

Time frame:
Within 48 hours of extubation, assessed through study completion up to maximum of 90 Days
Reported as:
Count of participants · Participants
Number of Participants With Extubation Failure
ParticipantsAcute: REDventAcute: Control
Number of Participants With Extubation Failure88
Statistical analysis
  • Acute: REDvent vs Acute: Control · Odds ratio (or): 1.0 · 95% CI 0.4 to 2.7
SecondaryNumber of Participants With Mortality

Death

Time frame:
Through study completion up to maximum of 90 Days
Reported as:
Count of participants · Participants
Number of Participants With Mortality
ParticipantsAcute: REDventAcute: Control
Number of Participants With Mortality2118
Statistical analysis
  • Acute: REDvent vs Acute: Control · Odds ratio (or): 1.04 · 95% CI 0.44 to 2.47
SecondaryMedian Maximal Inspiratory Airway Pressure During Airway Occlusion (aPiMax) at First Spontaneous Breathing Trial During Acute Phase.

Measured during standardized airway occlusion maneuvers

Time frame:
Assessed on the day of first spontaneous breathing trial up to 28 days
Reported as:
Median · centimeters of water
Median Maximal Inspiratory Airway Pressure During Airway Occlusion (aPiMax) at First Spontaneous Breathing Trial During Acute Phase.
centimeters of waterAcute: REDventAcute: Control
Median Maximal Inspiratory Airway Pressure During Airway Occlusion (aPiMax) at First Spontaneous Breathing Trial During Acute Phase.51.3 (36.7 to 65)44.0 (34 to 60)
Statistical analysis
  • Acute: REDvent vs Acute: Control · Proportional odds logistic regression: 1.60 · 95% CI 1.01 to 2.55
SecondaryMedian Maximal Inspiratory Esophageal Pressure During Airway Occlusion (ePiMax) During Acute Phase.

Measured during standardized airway occlusion maneuvers

Time frame:
Assessed on the day of first spontaneous breathing trial up to 28 days
Reported as:
Median · centimeters of water
Median Maximal Inspiratory Esophageal Pressure During Airway Occlusion (ePiMax) During Acute Phase.
centimeters of waterAcute: REDventAcute: Control
Median Maximal Inspiratory Esophageal Pressure During Airway Occlusion (ePiMax) During Acute Phase.41.09 (27.5 to 52.17)35.5 (26.1 to 49.0)
SecondaryMedian Percentage Change in Diaphragm Thickness on Exhalation (Dte) From Baseline During Acute Phase

From daily ultrasound measurement

Time frame:
Each day from study initiation until extubation up to a maximum of 28 days
Reported as:
Median · Percentage
Median Percentage Change in Diaphragm Thickness on Exhalation (Dte) From Baseline During Acute Phase
PercentageAcute: REDventAcute: Control
Median Percentage Change in Diaphragm Thickness on Exhalation (Dte) From Baseline During Acute Phase-2 (-25 to 14)-1 (-18 to 17)

Adverse events

Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Acute: REDvent16/125 (12.8%)19/125 (15.2%)18/125 (14.4%)
Acute: Control14/122 (11.5%)17/122 (13.9%)19/122 (15.6%)
Weaning: REDvent4/58 (6.9%)0/58 (0%)4/58 (6.9%)
Weaning: Control5/58 (8.6%)0/58 (0%)7/58 (12.1%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventAcute: REDventAcute: ControlWeaning: REDventWeaning: Control
Progressive multi-organ failureGeneral disorders4/1256/1220/580/58
Air leakRespiratory, thoracic and mediastinal disorders6/1253/1220/580/58
Cardiac Arrest/ECMOCardiac disorders1/1254/1220/580/58
Sustained hypoxemiaRespiratory, thoracic and mediastinal disorders3/1252/1220/580/58
Intracranial event/hemorrhageGeneral disorders2/1251/1220/580/58
Unplanned ExtubationInjury, poisoning and procedural complications0/1251/1220/580/58
Refractory shockGeneral disorders0/1251/1220/580/58
Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders0/1251/1220/580/58
ArrythmiaCardiac disorders1/1250/1220/580/58
BradycardiaCardiac disorders1/1250/1220/580/58
Most frequent other events
Most frequent other events
EventAcute: REDventAcute: ControlWeaning: REDventWeaning: Control
Sustained hypoxemiaRespiratory, thoracic and mediastinal disorders12/12515/1220/585/58
Failure of weaning phaseRespiratory, thoracic and mediastinal disorders——3/580/58
Esophageal catheter complicationInjury, poisoning and procedural complications0/1253/1220/581/58
Esphageal catheter in trachea-bronchial treeInjury, poisoning and procedural complications3/1250/1220/580/58
Re-intubationRespiratory, thoracic and mediastinal disorders1/1250/1221/581/58
Unplanned ExtubationInjury, poisoning and procedural complications2/1250/1221/580/58
BradycardiaCardiac disorders1/1252/1220/580/58
Air leakRespiratory, thoracic and mediastinal disorders1/1250/1220/580/58
ArrythmiaCardiac disorders1/1250/1220/580/58
Supra ventricular tachycardiaCardiac disorders1/1250/1220/580/58

Baseline characteristics

All patients at baseline started in Acute: REDvent and Acute: Control arms.

Age, Categorical
Age, Categorical(Participants)Acute: REDventAcute: ControlWeaning: RedventWeaning: ControlTotal
Acute Phase Randomization — <=18 years12011700237
Acute Phase Randomization — Between 18 and 65 years550010
Acute Phase Randomization — >=65 years00000
Age, Continuous
Age, Continuous(years)Acute: REDventAcute: ControlWeaning: RedventWeaning: ControlTotal
Acute Phase Randomization5.9 (1.6 to 13)4.9 (1.4 to 13.2)——5.6 (1.5 to 13.1)
Age, Customized
Age, Customized(Participants)Acute: REDventAcute: ControlWeaning: RedventWeaning: ControlTotal
Acute Phase Randomization — Infant20210041
Acute Phase Randomization — Child605900119
Acute Phase Randomization — Adolescents45420087
Sex: Female, Male
Sex: Female, Male(Participants)Acute: REDventAcute: ControlWeaning: RedventWeaning: ControlTotal
Acute Phase Randomization — Female546100115
Acute Phase Randomization — Male716100132
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Acute: REDventAcute: ControlWeaning: RedventWeaning: ControlTotal
Acute Phase Randomization — Hispanic or Latino728400156
Acute Phase Randomization — Not Hispanic or Latino43320075
Acute Phase Randomization — Unknown or Not Reported1060016
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Acute: REDventAcute: ControlWeaning: RedventWeaning: ControlTotal
Acute Phase Randomization — American Indian or Alaska Native00000
Acute Phase Randomization — Asian830011
Acute Phase Randomization — Native Hawaiian or Other Pacific Islander15006
Acute Phase Randomization — Black or African American1180019
Acute Phase Randomization — White32240056
Acute Phase Randomization — More than one race12003
Acute Phase Randomization — Unknown or Not Reported728000152
Region of Enrollment
Region of Enrollment(participants)Acute: REDventAcute: ControlWeaning: RedventWeaning: ControlTotal
United States125122——247
Number of Participants with Immunosuppression
Number of Participants with Immunosuppression(Participants)Acute: REDventAcute: ControlWeaning: RedventWeaning: ControlTotal
Count of participants35330068
07

Study locations

1 site
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
08

References and documents

Publications

  • Khemani RG, Bhalla A, Hotz JC, Klein MJ, Kwok J, Kohler K, Bornstein D, Chang D, Armenta-Quiroz A, Vu K, Smith E, Suresh A, Baron D, Bonilla-Cartagena J, Ross PA, Deakers T, Beltramo F, Nelson L, Shah S, Elkunovich M, Curley MAQ, Mack W, Newth CJL. Randomized Trial of Lung and Diaphragm Protective Ventilation in Children. NEJM Evid. 2025 Jun;4(6):EVIDoa2400360. doi: 10.1056/EVIDoa2400360. Epub 2025 May 27. PubMed 40423397 ↗
  • Vedrenne-Cloquet M, Ito Y, Hotz J, Klein MJ, Herrera M, Chang D, Bhalla AK, Newth CJL, Khemani RG. Phenotypes based on respiratory drive and effort to identify the risk factors when P0.1 fails to estimate ∆PES in ventilated children. Crit Care. 2024 Oct 4;28(1):325. doi: 10.1186/s13054-024-05103-x. PubMed 39367452 ↗
  • Ito Y, Herrera MG, Hotz JC, Kyogoku M, Newth CJL, Bhalla AK, Takeuchi M, Khemani RG. Estimation of inspiratory effort using airway occlusion maneuvers in ventilated children: a secondary analysis of an ongoing randomized trial testing a lung and diaphragm protective ventilation strategy. Crit Care. 2023 Nov 29;27(1):466. doi: 10.1186/s13054-023-04754-6. PubMed 38031116 ↗
  • Knox KE, Hotz JC, Newth CJL, Khoo MCK, Khemani RG. A 30-Minute Spontaneous Breathing Trial Misses Many Children Who Go On to Fail a 120-Minute Spontaneous Breathing Trial. Chest. 2023 Jan;163(1):115-127. doi: 10.1016/j.chest.2022.08.2212. Epub 2022 Aug 28. PubMed 36037984 ↗
  • van Dijk J, Blokpoel RGT, Abu-Sultaneh S, Newth CJL, Khemani RG, Kneyber MCJ. Clinical Challenges in Pediatric Ventilation Liberation: A Meta-Narrative Review. Pediatr Crit Care Med. 2022 Dec 1;23(12):999-1008. doi: 10.1097/PCC.0000000000003025. Epub 2022 Jul 14. PubMed 35830707 ↗
  • Shimatani T, Yoon B, Kyogoku M, Kyo M, Ohshimo S, Newth CJL, Hotz JC, Shime N, Khemani RG. Frequency and Risk Factors for Reverse Triggering in Pediatric Acute Respiratory Distress Syndrome during Synchronized Intermittent Mandatory Ventilation. Ann Am Thorac Soc. 2021 May;18(5):820-829. doi: 10.1513/AnnalsATS.202008-1072OC. PubMed 33326335 ↗
  • Khemani RG, Hotz JC, Klein MJ, Kwok J, Park C, Lane C, Smith E, Kohler K, Suresh A, Bornstein D, Elkunovich M, Ross PA, Deakers T, Beltramo F, Nelson L, Shah S, Bhalla A, Curley MAQ, Newth CJL. A Phase II randomized controlled trial for lung and diaphragm protective ventilation (Real-time Effort Driven VENTilator management). Contemp Clin Trials. 2020 Jan;88:105893. doi: 10.1016/j.cct.2019.105893. Epub 2019 Nov 16. PubMed 31740425 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 14, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-Identified IPD will be made available as per NIH guidelines.

Supporting information: Study protocol, Sap

09

Registry details

Key details

Study ID
NCT03266016
Lead sponsor
Children's Hospital Los Angeles
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Children's Hospital of Philadelphia
Responsible party
Robinder Khemani (Principal Investigator, Children's Hospital Los Angeles) — Principal investigator
First posted
Aug 29, 2017
Start date
Oct 21, 2017
Primary completion
Apr 1, 2024
Completion
Jun 20, 2024
Results posted
Jul 11, 2025
Last update
Sep 17, 2025

Study contacts

Robinder G Khemani, MD, MsCI
principal investigator · Children's Hospital Los Angeles

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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