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CompletedNCT01065428Updated Aug 31, 2011Results posted

Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure

An observational study in Respiratory Failure, sponsored by Southeast University, China. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-08-31.

Sponsored by Southeast University, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The aim of this study was to compare the indices of rapid shallow breathing, neuromechanical efficiency (NME), and neuroventilatory efficiency (NVE) between patients being successfully extubated and those who failed weaning.

Read the detailed description

Patients, mechanically ventilated for > 24 h, were included when they met criteria for their first spontaneous breathing trial (SBT) on continuous positive airway pressure (CPAP) (5-6 cmH2O) for 30 minutes. Patients who did not fulfill the criteria for successful SBT, or required assist, or deceased within 48h post-extubation were considered extubation failure (F). Patients who completed the SBT and remained extubated > 48 h were considered successfully extubated (S). Before and during the SBT, arterial blood gases, heart, rate, blood pressure, and EAdi, flow, Vt, f, and, airway pressure (Paw) were measured. At 0, 5, 10, 15 and 30 minutes of the SBT, f/Vt, diaphragm electrical activity (EAdi), NME, and NVE were calculated. NME was calculated as Paw/EAdi during inspiratory occlusion. NVE was calculated as Vt/EAdi during unassisted inspirations.Arterial blood gases, heart rate, and blood pressure were measured. The receiver operating characteristic (ROC) curve was calculated to evaluate the predictive performance of each index.

02

Conditions studied

  • Respiratory Failure

Keywords

  • neuromechanical efficiency
  • neuroventilatory efficiency
  • weaning
  • Respiration, Artificial
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 52 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who required mechanical ventilation for more than 24 h.

Inclusion criteria

  • We chose a number of eligible patients which were admitted to ICU of the Zhong-Da Hospital and required mechanical ventilation for more than 24 h.

Exclusion criteria

Exclusion Criteria:

(1) age \<18 or >85 years, (2) tracheostomy, (3) treatment abandonment, (4) history of esophageal varices, (5) gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days, (6) coagulation disorders (INR ratio>1.5 and APTT>44 s), (7) history of acute central or peripheral nervous system disorder or severe neuromuscular disease, (8) history of leukemia, severe chronic liver or chronic cardiac disease, (9) solid organ transplantation, (10) malignant tumor

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Weaning failure

    Weaning failure:(1) failed SBT; (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.

  • Weaning successful

    Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation

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What researchers measure

Primary outcomes

  1. Neuroventilatory Efficiency (NVE)

    NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.

    Time frame: at 30 minutes of the spontaneous breathing trials (SBT)

Secondary outcomes

  1. Neuromechanical Efficiency (NME)

    NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).

    Time frame: at 30 minutes of the spontaneous breathing trials (SBT)

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Results

Posted Nov 16, 2010
Limitations and caveats
Early termination leading to small numbers of subjects analyzed

Participant flow

In a 20 beds general ICU of a teaching hospital, from December 2008 to May 2010, 52 patients , mechanically ventilated for \> 24 h, were included when they deemed ready for extubation by the clinical team and fulfilled established weaning criteria.

Participant flow — Overall Study
MilestoneWeaning FailureWeaning Successful
Started1735
Completed1735
Not completed00

Outcome measures

PrimaryNeuroventilatory Efficiency (NVE)

NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.

Time frame:
at 30 minutes of the spontaneous breathing trials (SBT)
Reported as:
Mean · ml/uV
Neuroventilatory Efficiency (NVE)
ml/uVWeaning FailureWeaning Successful
Neuroventilatory Efficiency (NVE)17.6 ± 10.739.9 ± 23.9
Statistical analysis
  • Weaning Failure vs Weaning Successful · t-test, 2 sided · p = <0.05
SecondaryNeuromechanical Efficiency (NME)

NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).

Time frame:
at 30 minutes of the spontaneous breathing trials (SBT)
Reported as:
Mean · cmH2O/uV
Neuromechanical Efficiency (NME)
cmH2O/uVWeaning FailureWeaning Successful
Neuromechanical Efficiency (NME)1.13 ± 0.711.77 ± 0.79
Statistical analysis
  • Weaning Failure vs Weaning Successful · t-test, 2 sided · p = <0.05

Adverse events

Collected over During the 30 nints of SBT, and 48 hours after extubation. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Weaning Failure—0/17 (0%)0/17 (0%)
Weaning Successful—0/35 (0%)0/35 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Weaning FailureWeaning SuccessfulTotal
<=18 years000
Between 18 and 65 years11314
>=65 years162238
Age Continuous
Age Continuous(years)Weaning FailureWeaning SuccessfulTotal
Mean76.0 ± 6.465.2 ± 18.568.8 ± 16.4
Sex: Female, Male
Sex: Female, Male(Participants)Weaning FailureWeaning SuccessfulTotal
Female91120
Male82432
Region of Enrollment
Region of Enrollment(participants)Weaning FailureWeaning SuccessfulTotal
China173552
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Study locations

1 site
  • Nanjing Zhong-Da Hospital
    Nanjing, Jiangsu 21009, China
09

References and documents

Publications

  • Liu L, Liu H, Yang Y, Huang Y, Liu S, Beck J, Slutsky AS, Sinderby C, Qiu H. Neuroventilatory efficiency and extubation readiness in critically ill patients. Crit Care. 2012 Jul 31;16(4):R143. doi: 10.1186/cc11451. PubMed 22849707 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01065428
Lead sponsor
Southeast University, China
Collaborators
Unity Health Toronto
Responsible party
Ling Liu (Prof., Southeast University, China) — Principal investigator
First posted
Feb 9, 2010
Start date
Dec 2008
Primary completion
Jul 2010
Completion
Jul 2010
Results posted
Nov 16, 2010
Last update
Aug 31, 2011

Study contacts

Haibo Qiu, MD, Phd
study director · Southeast University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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