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.

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.

Study Overview

• Status: Unknown
• Conditions: Patients Receiving Protective Lung Ventilation; Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17
• Intervention / Treatment: Diagnostic test: lung recruitment maneuver

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

tertiary care center

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPV_augmented	augmented pulse pressure variation by lung recruitment maneuver	During the last 5 second of lung recruitment maneuver
SVV_augmented	augmented stroke volume variation by lung recruitment maneuver	During the last 5 second of lung recruitment maneuver

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ΔSV_LRM	The degree of reduction of stroke volume induced by lung recruitment maneuver	During the last 5 second of lung recruitment maneuver
ΔETCO2_LRM	The degree of reduction of end tidal CO2 concentration induced by lung recruitment maneuver	During the last 5 second of lung recruitment maneuver

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 7, 2019
• Primary Completion (ANTICIPATED): October 31, 2021
• Study Completion (ANTICIPATED): October 31, 2021

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (ACTUAL): October 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-07-004-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No