Driving Pressure and Postoperative Pulmonary Complications

Driving Pressure Limited Ventilation Decreases Postoperative Pulmonary Complications in One-Lung Ventilation: Randomized Controlled Study

This study aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.

Study Overview

• Status: Completed
• Conditions: Postoperative Respiratory Complications; One-Lung Ventilation; Driving Pressure
• Intervention / Treatment: Other: Driving Pressure Limited Ventilation

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults greater than or equal to 19 years
• Patient who undergoes one-lung ventilation for thoracic surgery

Exclusion Criteria:

• The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
• Patient who is contraindicated with application of positive end expiratory pressure
• Patient who rejects being enrolled in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Driving Pressure Limited Ventilation; The intervention arm receives driving pressure limited ventilation during one-lung ventilation	Other: Driving Pressure Limited Ventilation; Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 2 to 10 cmH2O during one-lung ventilation
No Intervention: Protective Ventilation; The control arm receives existing conventional protective ventilation with tidal volume of 6mL/kg of ideal body weight and positive end expiratory ventilation of 5cmH2O during one-lung ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative pulmonary complications	Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale.	within the first 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial pressure of oxygen in arterial blood		during surgery
The ratio of partial pressure arterial oxygen and fraction of inspired oxygen	The ratio will be obtained from the first arterial blood gas analysis on the first postoperative day.	on the first postoperative day

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Hyun Joo Ahn, Ph.D., Department of Anesthesiology and Pain Medicine, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2016
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SMC 2016-05-107-003