Oxygen Concentration During Alveolar Recruitment

July 13, 2020 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital

The Effect of Oxygen Concentration During Alveolar Recruitment on Absorption Atelectasis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: FiO2_1.0
Alveolar recruitment is performed with 100% oxygen concentration at specific time points.
Procedure: FiO2_1.0
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.
EXPERIMENTAL: FiO2_0.4
Alveolar recruitment is performed with 40% oxygen concentration at specific time points.
Procedure: FiO2_0.4
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified lung ultrasound score
Time Frame: Intraoperative (at the end of operation, before emergence)
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 (at the end of operation, before emergence)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified lung ultrasound score
Time Frame: Postoperative 30 minutes
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.
Postoperative 30 minutes
Intraoperative desaturation
Time Frame: Intraoperative
Oxygen saturation by pulse oximetry <95%
Intraoperative
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time Frame: Intraoperative (20minutes after each recruitment)
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Intraoperative (20minutes after each recruitment)
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time Frame: Postoperative 30 minutes
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Postoperative 30 minutes
Postoperative pulmonary complication
Time Frame: Postoperative 24 hours
respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis
Postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2019

Primary Completion (ACTUAL)

March 20, 2020

Study Completion (ACTUAL)

July 10, 2020

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (ACTUAL)

May 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHBahk_AR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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