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

July 26, 2020 updated by: Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fluid responder
patients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge.
Procedure: PEEP challenge
apply PEEP 10 mmHg in one-lung ventilating patients.
Experimental: fluid non-responder
patients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge
Procedure: PEEP challenge
apply PEEP 10 mmHg in one-lung ventilating patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulse pressure variation
Time Frame: 5 minutes after PEEP challenge
Temporary increase of PEEP will be able to predict fluid responsiveness using increase of pulse pressure variation over 1%.
5 minutes after PEEP challenge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stroke volume variation
Time Frame: 5 minutes after PEEP challenge
Temporary increase of PEEP will be able to predict fluid responsiveness using increase of stroke volume variation over 1%.
5 minutes after PEEP challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Kangnam Sacred Heart Hospital

Investigators

  • Study Chair: Eun-mi Choi, Professor, Kangnam Sungshim Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2019

Primary Completion (Actual)

June 26, 2020

Study Completion (Actual)

June 26, 2020

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 26, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-11-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

However, I can always share if required.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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