Back to resultsThe Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children
Primary Purpose
Atelectasis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
recruitment maneuver
ultrasonography-guided recruitment maneuver
Sponsored by
About this trial
This is an interventional prevention trial for Atelectasis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of lung surgery
- Abnormal findings in chest x-ray
- Laparoscopic surgery
- Abdominal surgery
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Recruitment maneuver group
Lung ultrasonography group
Arm Description
After anesthetic induction, recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.
After anesthetic induction, recruitment maneuver is performed, being guided by ultrasonography.
Outcomes
Primary Outcome Measures
Incidence of postoperative atelectasis
Postoperative atelectasis is measured using lung ultrasonography
Secondary Outcome Measures
Full Information
NCT ID
NCT03453762
First Posted
February 27, 2018
Last Updated
May 13, 2019
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03453762
Brief Title
The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children
Official Title
The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children - Effect of Ultrasonography Guided Recruitment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
March 1, 2019 (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
Yes
5. Study Description
Brief Summary
The investigators compare the degree of atelectasis in recovery room between conventional recruitment maneuver and ultrasonography-guided lung recruitment during surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recruitment maneuver group
Arm Type
Active Comparator
Arm Description
After anesthetic induction, recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.
Arm Title
Lung ultrasonography group
Arm Type
Experimental
Arm Description
After anesthetic induction, recruitment maneuver is performed, being guided by ultrasonography.
Intervention Type
Procedure
Intervention Name(s)
recruitment maneuver
Intervention Description
Recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.
Intervention Type
Procedure
Intervention Name(s)
ultrasonography-guided recruitment maneuver
Intervention Description
Recruitment maneuver is guided by ultrasonography.
Primary Outcome Measure Information:
Title
Incidence of postoperative atelectasis
Description
Postoperative atelectasis is measured using lung ultrasonography
Time Frame
within 1 hour after the end of surgery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
History of lung surgery
Abnormal findings in chest x-ray
Laparoscopic surgery
Abdominal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, 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
32068572
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children
We'll reach out to this number within 24 hrs