NCT03943433

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

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

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

May 7, 2019

Last Update Submit

July 13, 2020

Conditions

Atelectasis, Postoperative Pulmonary

Keywords

Absorption atelectasisLung sonoOxygen concentration

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. 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 Outcomes (5)

  • Modified lung ultrasound score

    Postoperative 30 minutes

  • Intraoperative desaturation

    Intraoperative

  • Intraoperative 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

    Postoperative 30 minutes

  • Postoperative pulmonary complication

    Postoperative 24 hours

Study Arms (2)

FiO2_1.0

ACTIVE COMPARATOR

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

Procedure: FiO2_1.0

FiO2_0.4

EXPERIMENTAL

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

Procedure: FiO2_0.4

Interventions

FiO2_1.0PROCEDURE

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.

FiO2_1.0
FiO2_0.4PROCEDURE

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.

FiO2_0.4

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32682397DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Jae-Hyon Bahk, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

May 15, 2019

Primary Completion

March 20, 2020

Study Completion

July 10, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

KR(1)