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Oxygen Concentration During Alveolar Recruitment

Primary Purpose

Atelectasis, Postoperative Pulmonary

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FiO2_1.0
FiO2_0.4
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis, Postoperative Pulmonary focused on measuring Absorption atelectasis, Lung sono, Oxygen concentration

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position

Exclusion Criteria:

  • American Society of Anesthesiologists physical status IV or more
  • Severe cardiovascular disease
  • Severe chronic obstructive pulmonary disease, emphysema
  • History of pneumothorax, bullae
  • History of lung resection surgery
  • Conversion to laparotomy
  • Refusal to participate

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FiO2_1.0

FiO2_0.4

Arm Description

Alveolar recruitment is performed with 100% oxygen concentration at specific time points.

Alveolar recruitment is performed with 40% oxygen concentration at specific time points.

Outcomes

Primary Outcome Measures

Modified lung ultrasound score
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)~3 (severe atelectasis), so the maximum total score is 36.

Secondary Outcome Measures

Modified lung ultrasound score
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)~3 (severe atelectasis), so the maximum total score is 36.
Intraoperative desaturation
Oxygen saturation by pulse oximetry <95%
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Postoperative pulmonary complication
respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis

Full Information

First Posted
May 7, 2019
Last Updated
July 13, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03943433
Brief Title
Oxygen Concentration During Alveolar Recruitment
Official Title
The Effect of Oxygen Concentration During Alveolar Recruitment on Absorption Atelectasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
July 10, 2020 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Postoperative Pulmonary
Keywords
Absorption atelectasis, Lung sono, Oxygen concentration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FiO2_1.0
Arm Type
Active Comparator
Arm Description
Alveolar recruitment is performed with 100% oxygen concentration at specific time points.
Arm Title
FiO2_0.4
Arm Type
Experimental
Arm Description
Alveolar recruitment is performed with 40% oxygen concentration at specific time points.
Intervention Type
Procedure
Intervention Name(s)
FiO2_1.0
Intervention Description
Alveolar recruitment is performed with 100% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.
Intervention Type
Procedure
Intervention Name(s)
FiO2_0.4
Intervention Description
Alveolar recruitment is performed with 40% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.
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. Each quadrant score ranges from 0 (minimal atelectasis)~3 (severe atelectasis), so the maximum total score is 36.
Time Frame
Intraoperative (at the end of operation, before emergence)
Secondary 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. Each quadrant score ranges from 0 (minimal atelectasis)~3 (severe atelectasis), so the maximum total score is 36.
Time Frame
Postoperative 30 minutes
Title
Intraoperative desaturation
Description
Oxygen saturation by pulse oximetry <95%
Time Frame
Intraoperative
Title
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Description
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time Frame
Intraoperative (20minutes after each recruitment)
Title
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Description
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time Frame
Postoperative 30 minutes
Title
Postoperative pulmonary complication
Description
respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis
Time Frame
Postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position Exclusion Criteria: American Society of Anesthesiologists physical status IV or more Severe cardiovascular disease Severe chronic obstructive pulmonary disease, emphysema History of pneumothorax, bullae History of lung resection surgery Conversion to laparotomy 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

Citations:
PubMed Identifier
32682397
Citation
Kim BR, Lee S, Bae H, Lee M, Bahk JH, Yoon S. Lung ultrasound score to determine the effect of fraction inspired oxygen during alveolar recruitment on absorption atelectasis in laparoscopic surgery: a randomized controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):173. doi: 10.1186/s12871-020-01090-y.
Results Reference
derived

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Oxygen Concentration During Alveolar Recruitment

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