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Optimal Level of PEEP in Protective One-lung Ventilation

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEEP 3 cm of water
PEEP 6 cm of water
PEEP 9 cm of water
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Video-assisted Thoracic Surgery focused on measuring Protective ventilation, One-lung ventilation

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PEEP 3 cm of water

PEEP 6 cm of water

PEEP 9 cm of water

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intraoperative desaturation
Oxygen saturation by pulse oximetry <95% during one-lung ventilation
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
partial pressure of arterial oxygen/fraction of inspired oxygen ratio during one-lung ventilation
Postoperative desaturation
Oxygen saturation by pulse oximetry <95%
plasma Tumor Necrosis Factor-α
proinflammatory cytokine
plasma Interleukin-6
proinflammatory cytokine
plasma Interleukin-10
anti-inflammatory cytokine
Postoperative pulmonary complication
Composite outcome of atelectasis, pneumonia, acute respiratory distress syndrome, or pulmonary aspiration

Full Information

First Posted
February 26, 2019
Last Updated
April 15, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03856918
Brief Title
Optimal Level of PEEP in Protective One-lung Ventilation
Official Title
Optimal Level of Positive End-expiratory Pressure to Reduce Postoperative Atelectasis After Lung Resection With Protective One-lung Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Video-assisted Thoracic Surgery, Postoperative Atelectasis, Positive End-expiratory Pressure
Keywords
Protective ventilation, One-lung ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEP 3 cm of water
Arm Type
Experimental
Arm Description
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.
Arm Title
PEEP 6 cm of water
Arm Type
Experimental
Arm Description
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.
Arm Title
PEEP 9 cm of water
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PEEP 3 cm of water
Intervention Description
PEEP of 3 cm of water will be applied during one-lung ventilation.
Intervention Type
Procedure
Intervention Name(s)
PEEP 6 cm of water
Intervention Description
PEEP of 6 cm of water will be applied during one-lung ventilation.
Intervention Type
Procedure
Intervention Name(s)
PEEP 9 cm of water
Intervention Description
PEEP of 9 cm of water will be applied during one-lung ventilation.
Primary Outcome Measure Information:
Title
Modified lung ultrasound score
Description
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.
Time Frame
Postoperative 1 hour
Secondary Outcome Measure Information:
Title
Intraoperative desaturation
Description
Oxygen saturation by pulse oximetry <95% during one-lung ventilation
Time Frame
Average time of 60-90 minutes
Title
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Description
partial pressure of arterial oxygen/fraction of inspired oxygen ratio during one-lung ventilation
Time Frame
Average time of 60-90 minutes
Title
Postoperative desaturation
Description
Oxygen saturation by pulse oximetry <95%
Time Frame
Postoperative 24 hours
Title
plasma Tumor Necrosis Factor-α
Description
proinflammatory cytokine
Time Frame
10 minutes after initiation of one-lung ventilation
Title
plasma Interleukin-6
Description
proinflammatory cytokine
Time Frame
10 minutes after initiation of one-lung ventilation
Title
plasma Interleukin-10
Description
anti-inflammatory cytokine
Time Frame
10 minutes after initiation of one-lung ventilation
Title
Postoperative pulmonary complication
Description
Composite outcome of atelectasis, pneumonia, acute respiratory distress syndrome, or pulmonary aspiration
Time Frame
Postoperative 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Hyon Bahk, MD,PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Optimal Level of PEEP in Protective One-lung Ventilation

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