NCT03856918

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

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

First Submitted

Initial submission to the registry

February 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

February 26, 2019

Last Update Submit

April 15, 2022

Conditions

Video-assisted Thoracic SurgeryPostoperative AtelectasisPositive End-expiratory Pressure

Keywords

Protective ventilationOne-lung ventilation

Outcome Measures

Primary Outcomes (1)

  • Modified lung ultrasound score

    The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.

    Postoperative 1 hour

Secondary Outcomes (7)

  • Intraoperative desaturation

    Average time of 60-90 minutes

  • Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio

    Average time of 60-90 minutes

  • Postoperative desaturation

    Postoperative 24 hours

  • plasma Tumor Necrosis Factor-α

    10 minutes after initiation of one-lung ventilation

  • plasma Interleukin-6

    10 minutes after initiation of one-lung ventilation

  • +2 more secondary outcomes

Study Arms (3)

PEEP 3 cm of water

EXPERIMENTAL

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.

Procedure: PEEP 3 cm of water

PEEP 6 cm of water

EXPERIMENTAL

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.

Procedure: PEEP 6 cm of water

PEEP 9 cm of water

EXPERIMENTAL

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.

Procedure: PEEP 9 cm of water

Interventions

PEEP 3 cm of waterPROCEDURE

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

PEEP 3 cm of water
PEEP 6 cm of waterPROCEDURE

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

PEEP 6 cm of water
PEEP 9 cm of waterPROCEDURE

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

PEEP 9 cm of water

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Positive-Pressure RespirationWater

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory TherapyHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Jae-Hyon Bahk, MD,PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 27, 2019

Study Start

May 28, 2019

Primary Completion

February 11, 2020

Study Completion

February 28, 2021

Last Updated

April 18, 2022

Record last verified: 2022-04

Locations

KR(1)