NCT02851238

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

August 12, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

July 28, 2016

Last Update Submit

October 4, 2018

Conditions

One-Lung VentilationPostoperative Respiratory ComplicationsDriving Pressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Partial pressure of oxygen in arterial blood

    during surgery

  • The ratio of partial pressure arterial oxygen and fraction of inspired oxygen

    on the first postoperative day

Study Arms (2)

Protective Ventilation

NO INTERVENTION

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

Driving Pressure Limited Ventilation

EXPERIMENTAL

The intervention arm receives driving pressure limited ventilation during one-lung ventilation

Other: Driving Pressure Limited Ventilation

Interventions

Driving Pressure Limited VentilationOTHER

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

Driving Pressure Limited Ventilation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, 135-710, South Korea

Location

Study Officials

  • Hyun Joo Ahn, Ph.D.

    Department of Anesthesiology and Pain Medicine, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

August 12, 2016

Primary Completion

August 31, 2017

Study Completion

September 1, 2017

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

KR(1)