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Application of High Flow Nasal Cannula for Prevention of Post-extubation Atelectasis in Children Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT03817177
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

Brief Summary:
postoperative atelectasis observation by ultrasound after application of high flow nasal cannula oxygenation

Condition or disease Intervention/treatment Phase
Atelectasis Procedure: high flow nasal cannula oxygenation Procedure: nasal prong Not Applicable

Detailed Description:
After surgery, postoperative atelectasis observation by ultrasound grading comparison between application of conventional nasal prong and high flow nasal cannula device

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Seoul National University Hospital Department of Anesthesiology and Pain Medicine
Actual Study Start Date : March 2, 2019
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
Placebo Comparator: nasal prong
conventional nasal prong application after the surgery in postanesthetic care unit (PACU)
Procedure: nasal prong
conventional nasal prong application in PACU

Experimental: high flow nasal cannula oxygenation
high flow nasal cannula application after the surgery in postanesthetic care unit (PACU)
Procedure: high flow nasal cannula oxygenation
high flow nasal cannula application in PACU




Primary Outcome Measures :
  1. lung sound score [ Time Frame: 30 minutes after arrival of postanesthetic care unit ]

    0: Normal aeration (N): presence of lung sliding with A lines or fewer than two isolated B lines

    1. Moderate loss of lung aeration: multiple well-defined B lines (B1 lines)
    2. Severe loss of lung aeration: multiple coalescent B lines (B2 lines)
    3. Lung consolidation (C): the presence of a tissue pattern characterized by dynamic air



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • general anesthesia

Exclusion Criteria:

  • preterm
  • bronchopulmonary dysplasia
  • upper respiratory infection history
  • respiratory disease
  • cardiac surgery

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): NCT03817177


Contacts
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Contact: Hee-Soo Kim, MD, Phd 0220723659 dami0605@snu.ac.kr
Contact: Ji-Hyun Lee, MD, PHd 0220723664

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Heesoo Kim         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee-Soo Kim Seoul National University Children's Hospital

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Responsible Party: Hee-Soo Kim, principle investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03817177     History of Changes
Other Study ID Numbers: 1812-111-998
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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