- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03453762
The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children
May 13, 2019 updated by: Jin-Tae Kim, Seoul National University Hospital
The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children - Effect of Ultrasonography Guided Recruitment
The investigators compare the degree of atelectasis in recovery room between conventional recruitment maneuver and ultrasonography-guided lung recruitment during surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
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
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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-
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
No older than 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Recruitment maneuver group
After anesthetic induction, recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.
|
Recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.
|
|
Experimental: Lung ultrasonography group
After anesthetic induction, recruitment maneuver is performed, being guided by ultrasonography.
|
Recruitment maneuver is guided by ultrasonography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative atelectasis
Time Frame: within 1 hour after the end of surgery
|
Postoperative atelectasis is measured using lung ultrasonography
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within 1 hour after the end of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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)
March 23, 2018
Primary Completion (Actual)
February 20, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
February 27, 2018
First Submitted That Met QC Criteria
February 27, 2018
First Posted (Actual)
March 5, 2018
Study Record Updates
Last Update Posted (Actual)
May 15, 2019
Last Update Submitted That Met QC Criteria
May 13, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H1802-058-921
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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