Optimal Level of PEEP in Protective One-lung Ventilation

April 15, 2022 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital

Optimal Level of Positive End-expiratory Pressure to Reduce Postoperative Atelectasis After Lung Resection With Protective One-lung Ventilation

Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

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

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation

Exclusion Criteria:

  • Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test
  • Chronic kidney disease
  • Coronary artery disease
  • Pulmonary hypertension
  • Bilateral lung surgery
  • Conversion to thoracotomy
  • American Society of Anesthesiologists physical status IV or more
  • Refusal to participate

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEEP 3 cm of water
Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 3 cm of water during thoracic surgery.
Procedure: PEEP 3 cm of water
PEEP of 3 cm of water will be applied during one-lung ventilation.
EXPERIMENTAL: PEEP 6 cm of water
Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 6 cm of water during thoracic surgery.
Procedure: PEEP 6 cm of water
PEEP of 6 cm of water will be applied during one-lung ventilation.
EXPERIMENTAL: PEEP 9 cm of water
Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 9 cm of water during thoracic surgery.
Procedure: PEEP 9 cm of water
PEEP of 9 cm of water will be applied during one-lung ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified lung ultrasound score
Time Frame: Postoperative 1 hour
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.
Postoperative 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative desaturation
Time Frame: Average time of 60-90 minutes
Oxygen saturation by pulse oximetry <95% during one-lung ventilation
Average time of 60-90 minutes
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time Frame: Average time of 60-90 minutes
partial pressure of arterial oxygen/fraction of inspired oxygen ratio during one-lung ventilation
Average time of 60-90 minutes
Postoperative desaturation
Time Frame: Postoperative 24 hours
Oxygen saturation by pulse oximetry <95%
Postoperative 24 hours
plasma Tumor Necrosis Factor-α
Time Frame: 10 minutes after initiation of one-lung ventilation
proinflammatory cytokine
10 minutes after initiation of one-lung ventilation
plasma Interleukin-6
Time Frame: 10 minutes after initiation of one-lung ventilation
proinflammatory cytokine
10 minutes after initiation of one-lung ventilation
plasma Interleukin-10
Time Frame: 10 minutes after initiation of one-lung ventilation
anti-inflammatory cytokine
10 minutes after initiation of one-lung ventilation
Postoperative pulmonary complication
Time Frame: Postoperative 7 days
Composite outcome of atelectasis, pneumonia, acute respiratory distress syndrome, or pulmonary aspiration
Postoperative 7 days

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Hyon Bahk, MD,PhD, Seoul National University 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)

May 28, 2019

Primary Completion (ACTUAL)

February 11, 2020

Study Completion (ACTUAL)

February 28, 2021

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (ACTUAL)

February 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1901-086-1004

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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