ClinicalTrials.gg
CompletedNCT04118244Updated Jan 29, 2026

A Functional Test to Assess Fluid Status During Lung Protective Ventilation Strategies

An observational study in Patients Receiving Protective Lung Ventilation and Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17, sponsored by Hallym University Kangnam Sacred Heart Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Hallym University Kangnam Sacred Heart Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
48
Ages
20 Years to 80 Years
Sex
All
01

Study summary

Dynamic preload indices, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are generally accepted as accurate indicator of fluid responsiveness in mechanically ventilated patients. Because SVV and PPV are generated by the pressure transmitted from the airways to the pleural and pericardial spaces, their reliability is limited in patients receiving low tidal volume (VT) ventilation and in those with a driving pressure lower than 20 cm H2O.

Lung-protective ventilation using low VT with positive end expiratory pressure (PEEP) has recently been demonstrated to significantly improve postoperative outcome, and its application is gradually increasing in surgical patients. However, protective ventilation alters the predictability of dynamic preload indices and thus limits their use in the operating theatre.

Lung recruitment maneuvers (LRMs), used to reopen collapsed lung, and PEEP have been proposed as the key components of lung-protective ventilation strategy. LRM increases intrathoracic pressure, which in turn causes a transient decrease in stroke volume (SV) and arterial pressure; this may depend on preload status. Interestingly, recent study reported that the augmented PPV during LRM using vital capacity maneuver (VCM, continuous positive airway pressure of 30 cm H2O for 10 s) could predict preload responsiveness under open chest condition.

Investigators hypothesized that the augmented PPV and SVV by a stepwise LRM with incremental PEEP could represent a functional test to suggest preload responsiveness and, therefore, predict fluid responsiveness. The aims of the current study were (1) to assess the ability of augmented PPV and SVV during stepwise LRM-induced to predict fluid responsiveness in mechanically ventilated patients in the operating room, (2) to assess the ability of stepwise LRM-induced decrease in SV (ΔSV-LRM) to predict fluid responsiveness.

02

Conditions studied

  • Patients Receiving Protective Lung Ventilation
  • Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17
03

In context

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital is the lead sponsor of 34 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

tertiary care center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients receiving laparotomy and lung protective ventilation

Exclusion criteria

Exclusion Criteria:

  • preoperative arrhythmia
  • Severe bradycardia
  • Moderate to severe valvular disease
  • \< 50%
  • Poorly controlled hypertension (systolic BP > 160 mmHg)
  • Patients with renal insufficiency (creatinine > 1.5 mg/dL)
  • Moderate to severe liver disease
  • >.30 or \< 15 kg/ m2
  • preexisting pulmonary disease
  • \< 60% of predicted value
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
48 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testlung recruitment maneuver

    The ventilator was switched to pressure control ventilation, inspiratory time was increased to 50%, the peak inspiratory pressure gradient (above PEEP) was set at 15cm H2O, and PEEP was progressively increased to obtain a stepwise increase of peak inspiratory to 20, 25, and 30 cm H2O every three breaths. The final recruiting pressure of 30 cm H2O was applied for six breaths.

06

What researchers measure

Primary outcomes

  1. PPV_augmented

    augmented pulse pressure variation by lung recruitment maneuver

    Time frame: During the last 5 second of lung recruitment maneuver

  2. SVV_augmented

    augmented stroke volume variation by lung recruitment maneuver

    Time frame: During the last 5 second of lung recruitment maneuver

Secondary outcomes

  1. ΔSV_LRM

    The degree of reduction of stroke volume induced by lung recruitment maneuver

    Time frame: During the last 5 second of lung recruitment maneuver

  2. ΔETCO2_LRM

    The degree of reduction of end tidal CO2 concentration induced by lung recruitment maneuver

    Time frame: During the last 5 second of lung recruitment maneuver

07

Study locations

1 site
  • Kangnam Sacred Heart Hospital, Hallym University College of Medicine
    Seoul, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2019 to primary completion in Oct 2021, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2019
First posted
Oct 8, 2019
StartActual
Oct 7, 2019
Primary completionActual
Oct 31, 2021
CompletionActual
Oct 31, 2021
Last update
Jan 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04118244
Lead sponsor
Hallym University Kangnam Sacred Heart Hospital
Responsible party
Jun joohyun (Assistant Professor, Hallym University Kangnam Sacred Heart Hospital) — Principal investigator
First posted
Oct 8, 2019
Start date
Oct 7, 2019
Primary completion
Oct 31, 2021
Completion
Oct 31, 2021
Last update
Jan 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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