Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation

Not Applicable

Completed

• Conditions: Lung Diseases; Lung Cancer
• Interventions: Procedure: PEEP challenge

• Registration Number: NCT03794414
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

Brief Summary

The present study is to evaluate the effect of positive end-expiratory pressure (PEEP) in predicting fluid responsiveness in patients undergoing one-lung ventilation.

Detailed Description

Appropriate fluid challenge is crucial during lung surgery under one-lung ventilation. Applying PEEP in mechanically ventilating patients changes dynamic hemodynamic parameters (stroke volume variation, pulse pressure variation), which is more pronounced in hypovolemic patients. The aim of the present study is to evaluate the mechanically ventilating patients under one-lung ventilation requiring fluid resuscitation by applying PEEP to predict fluid responsiveness.

The investigators hypothesized that applying PEEP in one-lung ventilating patients can also change dynamic parameters and the magnitude of the change of stroke volume variation, pulse pressure variation can predict fluid responsiveness. The investigator applied PEEP 10 mmHg in one-lung ventilating patients and observed the dynamic parameters including stroke volume variation, pulse pressure variation and then infused 6ml/kg of crystalloid for fluid challenge and diagnosed fluid responsiveness as 10% increase of stroke volume after fluid challenge.

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Study Start: 2019-01-31
• Primary Completion: 2020-06-26
• Study Completion: 2020-06-26
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-26
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients undergoing lung surgery under one-lung ventilation

Exclusion Criteria

• arrhythmia
• moderate to severe valvular heart disease moderate to severe pericardial effusion left ventricular ejection fraction < 40%
• moderate to severe chronic obstructive lung disease
• unable to insert oesophageal Doppler Monitor (ODM) probe ( esophageal stent, esophageal cancer, previous esophageal surgery, esophageal stricture, esophageal varices, pharyngeal pouch and severe coagulopathy )
• patient refusal
• cannot understand the protocol
• less than 50kg or over 100kg in weight

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fluid non-responder	PEEP challenge	patients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge
fluid responder	PEEP challenge	patients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge.

Primary Outcome Measures

Name	Time	Method
pulse pressure variation	5 minutes after PEEP challenge	Temporary increase of PEEP will be able to predict fluid responsiveness using increase of pulse pressure variation over 1%.

Secondary Outcome Measures

Name	Time	Method
stroke volume variation	5 minutes after PEEP challenge	Temporary increase of PEEP will be able to predict fluid responsiveness using increase of stroke volume variation over 1%.

Trial Locations

Locations (1)

Kangnam Sungshim Hospital; 🇰🇷 Seoul, Korea, Republic of