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NCT04118244

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

Completed Last updated 29 January 2026
What this trial tests

trial testing lung recruitment maneuver in Patients Receiving Protective Lung Ventilation in 48 participants. Completed in 31 October 2021.

Timeline
7 October 2019
Primary endpoint
31 October 2021
31 October 2021

Quick facts

Lead sponsorHallym University Kangnam Sacred Heart Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment48
Start date7 October 2019
Primary completion31 October 2021
Estimated completion31 October 2021
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Hallym University Kangnam Sacred Heart Hospital

Who can join

Adults 20 to 80, any sex, with Patients Receiving Protective Lung Ventilation or Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Use of stepwise lung recruitment maneuver to predict fluid responsiveness under lung protective ventilation in the operating room.
    Chun EH, Chung MH, Kim JE, Lee HS, et al · · 2024 · PMID 38773192 · DOI 10.1038/s41598-024-62355-x

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