Skip to content

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

Development of a Functional Test to Assess Fluid Status During Lung Protective Ventilation Strategies in the Operating Room.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04118244
Enrollment
48
Registered
2019-10-08
Start date
2019-10-07
Completion date
2021-10-31
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

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.

Sponsors

Hallym University Kangnam Sacred Heart Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years

Inclusion criteria

* Adult patients receiving laparotomy and lung protective ventilation

Exclusion criteria

* preoperative arrhythmia * Severe bradycardia * Moderate to severe valvular disease * left ventricular ejection fraction \< 50% * Poorly controlled hypertension (systolic BP \> 160 mmHg) * Patients with renal insufficiency (creatinine \> 1.5 mg/dL) * Moderate to severe liver disease * BMI \>.30 or \< 15 kg/ m2 * preexisting pulmonary disease * FEV1 \< 60% of predicted value

Design outcomes

Primary

MeasureTime frameDescription
PPV_augmentedDuring the last 5 second of lung recruitment maneuveraugmented pulse pressure variation by lung recruitment maneuver
SVV_augmentedDuring the last 5 second of lung recruitment maneuveraugmented stroke volume variation by lung recruitment maneuver

Secondary

MeasureTime frameDescription
ΔSV_LRMDuring the last 5 second of lung recruitment maneuverThe degree of reduction of stroke volume induced by lung recruitment maneuver
ΔETCO2_LRMDuring the last 5 second of lung recruitment maneuverThe degree of reduction of end tidal CO2 concentration induced by lung recruitment maneuver

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026