Protective Ventilation Strategy

Protective Ventilation Strategy During One-lung Ventilation: Effect on Postoperative Pulmonary Complications

The purpose of this study is to find a proper ventilation strategy for one-lung ventilation to prevent postoperative pulmonary complications

Study Overview

• Status: Completed
• Conditions: One-lung Ventilation
• Intervention / Treatment: Other: ventilator setting during one-lung ventilation

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients undergoing elective thoracic surgery
• ASA I, II, III
• scheduled > 2 hours of surgery

Exclusion Criteria:

• denied patients
• age under 18 years
• FEV1/FVC or FEV1<70% in preoperative pulmonary function test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional tidal group; provide tidal volume of 6ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation	Other: ventilator setting during one-lung ventilation; providing various tidal volumes according to the groups with constant PEEP
Experimental: low tidal group; provide tidal volume of 4ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation	Other: ventilator setting during one-lung ventilation; providing various tidal volumes according to the groups with constant PEEP
Experimental: high tidal group; provide tidal volume of 8ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation	Other: ventilator setting during one-lung ventilation; providing various tidal volumes according to the groups with constant PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pulmonary complications	PaO2/FiO2 and/or newly appeared atelectasis, lung infiltration	immediately after operation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: protective ventilation strategy
• Other Study ID Numbers: JHBahk_PV

Drug and device information, study documents

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