NCT03234621

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

April 16, 2024

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

July 26, 2017

Last Update Submit

April 12, 2024

Conditions

One-lung Ventilation

Keywords

protective ventilation strategy

Outcome Measures

Primary Outcomes (1)

  • postoperative pulmonary complications

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

    immediately after operation

Study Arms (3)

conventional tidal group

EXPERIMENTAL

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

low tidal group

EXPERIMENTAL

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

high tidal group

EXPERIMENTAL

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

Interventions

ventilator setting during one-lung ventilationOTHER

providing various tidal volumes according to the groups with constant PEEP

conventional tidal grouphigh tidal grouplow tidal group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 31, 2017

Study Start

July 12, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

April 16, 2024

Record last verified: 2017-07

Locations

KR(1)