NCT03453762

Brief Summary

The investigators compare the degree of atelectasis in recovery room between conventional recruitment maneuver and ultrasonography-guided lung recruitment during surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

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 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

March 23, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

February 27, 2018

Last Update Submit

May 13, 2019

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative atelectasis

    Postoperative atelectasis is measured using lung ultrasonography

    within 1 hour after the end of surgery

Study Arms (2)

Recruitment maneuver group

ACTIVE COMPARATOR

After anesthetic induction, recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.

Procedure: recruitment maneuver

Lung ultrasonography group

EXPERIMENTAL

After anesthetic induction, recruitment maneuver is performed, being guided by ultrasonography.

Procedure: ultrasonography-guided recruitment maneuver

Interventions

recruitment maneuverPROCEDURE

Recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.

Recruitment maneuver group
ultrasonography-guided recruitment maneuverPROCEDURE

Recruitment maneuver is guided by ultrasonography.

Lung ultrasonography group

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients who undergo surgery for more than 1 hour under general anesthesia
  • Children under 6 years old
  • American Society of Anesthesiologist Physical Status I or II

You may not qualify if:

  • History of lung surgery
  • Abnormal findings in chest x-ray
  • Laparoscopic surgery
  • Abdominal surgery

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)

  • Lee JH, Choi S, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Effect of an ultrasound-guided lung recruitment manoeuvre on postoperative atelectasis in children: A randomised controlled trial. Eur J Anaesthesiol. 2020 Aug;37(8):719-727. doi: 10.1097/EJA.0000000000001175.

    PMID: 32068572DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Jin-Tae Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

March 23, 2018

Primary Completion

February 20, 2019

Study Completion

March 1, 2019

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations

KR(1)