Driving Pressure and Postoperative Pulmonary Complications

NCT ID: NCT02851238

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-12

Study Completion Date

2017-09-01

Brief Summary

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

Detailed Description

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Conditions

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One-Lung Ventilation Postoperative Respiratory Complications Driving Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

Driving Pressure Limited Ventilation

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

Group Type EXPERIMENTAL

Driving Pressure Limited Ventilation

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyun Joo Ahn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Joo Ahn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Samsung Medical Center

Locations

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Samsung medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SMC 2016-05-107-003

Identifier Type: -

Identifier Source: org_study_id

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