Optimal Level of PEEP in Protective One-lung Ventilation

NCT ID: NCT03856918

Last Updated: 2022-04-18

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

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2021-02-28

Brief Summary

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Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.

Detailed Description

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Conditions

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Video-assisted Thoracic Surgery Postoperative Atelectasis Positive End-expiratory Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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PEEP 3 cm of water

Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 3 cm of water during thoracic surgery.

Group Type EXPERIMENTAL

PEEP 3 cm of water

Intervention Type PROCEDURE

PEEP of 3 cm of water will be applied during one-lung ventilation.

PEEP 6 cm of water

Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 6 cm of water during thoracic surgery.

Group Type EXPERIMENTAL

PEEP 6 cm of water

Intervention Type PROCEDURE

PEEP of 6 cm of water will be applied during one-lung ventilation.

PEEP 9 cm of water

Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 9 cm of water during thoracic surgery.

Group Type EXPERIMENTAL

PEEP 9 cm of water

Intervention Type PROCEDURE

PEEP of 9 cm of water will be applied during one-lung ventilation.

Interventions

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PEEP 3 cm of water

PEEP of 3 cm of water will be applied during one-lung ventilation.

Intervention Type PROCEDURE

PEEP 6 cm of water

PEEP of 6 cm of water will be applied during one-lung ventilation.

Intervention Type PROCEDURE

PEEP 9 cm of water

PEEP of 9 cm of water will be applied during one-lung ventilation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation

Exclusion Criteria

* Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test
* Chronic kidney disease
* Coronary artery disease
* Pulmonary hypertension
* Bilateral lung surgery
* Conversion to thoracotomy
* American Society of Anesthesiologists physical status IV or more
* Refusal to participate
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Hyon Bahk, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Hyon Bahk, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1901-086-1004

Identifier Type: -

Identifier Source: org_study_id

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