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Clinical Trials/NCT03234621
NCT03234621CompletedNot Applicable

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

Seoul National University Hospital1 site in 1 country87 target enrollmentStarted: July 12, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
87
Locations
1
Primary Endpoint
postoperative pulmonary complications

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

conventional tidal group

Experimental

provide tidal volume of 6ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation

Intervention: ventilator setting during one-lung ventilation (Other)

low tidal group

Experimental

provide tidal volume of 4ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation

Intervention: ventilator setting during one-lung ventilation (Other)

high tidal group

Experimental

provide tidal volume of 8ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation

Intervention: ventilator setting during one-lung ventilation (Other)

Outcomes

Primary Outcomes

postoperative pulmonary complications

Time Frame: immediately after operation

PaO2/FiO2 and/or newly appeared atelectasis, lung infiltration

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jae-Hyon Bahk, MD, PhD

Professor

Seoul National University Hospital

Study Sites (1)

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