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The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453762
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Atelectasis Procedure: recruitment maneuver Procedure: ultrasonography-guided recruitment maneuver Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children - Effect of Ultrasonography Guided Recruitment
Actual Study Start Date : March 23, 2018
Actual Primary Completion Date : February 20, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Recruitment maneuver group
After anesthetic induction, recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.
 Procedure: recruitment maneuver
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.
 Procedure: ultrasonography-guided recruitment maneuver
Recruitment maneuver is guided by ultrasonography.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of postoperative atelectasis [ Time Frame: within 1 hour after the end of surgery ]
    Postoperative atelectasis is measured using lung ultrasonography


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453762


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, MD, PhD Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03453762    
Other Study ID Numbers: H1802-058-921
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases