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Completed

NCT Number: NCT04118244

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Seoul, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lung recruitment maneuver

Diagnostic Test

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.

Primary outcomes

  1. PPV_augmented

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

    augmented pulse pressure variation by lung recruitment maneuver

  2. SVV_augmented

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

    augmented stroke volume variation by lung recruitment maneuver

Secondary outcomes

  1. ΔSV_LRM

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

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

  2. ΔETCO2_LRM

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

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

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2019
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.