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PEEP During Induction of Anesthesia in Small Children

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ClinicalTrials.gov Identifier: NCT03540940
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

Brief Summary:
Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric patients arterial desaturation during induction of anesthesia develops rapidly, we studied the clinical benefit of PEEP applied during anesthesia induction.

Condition or disease Intervention/treatment Phase
Pediatric Anesthesia Other: PEEP Other: ZEEP Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia on Atelectasis Formation and Non-hypoxic Apnea Time in Small Children: a Randomized Controlled Trials
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : May 31, 2019

Arm Intervention/treatment
Experimental: zero positive end expiratory pressure Other: ZEEP
0 cmH2O positive end expiratory pressure

Experimental: Positive end expiratory pressure Other: PEEP
6cmH2O positive end expiratory pressure




Primary Outcome Measures :
  1. Duration of Apnea [ Time Frame: from the start of apnea until SpO2 reached 95%, maximum 5 minutes. ]


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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pediatric patients undergoing general anesthesia using endotracheal intubation

Exclusion Criteria:

  • previous history of lung disease
  • anticipated difficulty in airway management

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): NCT03540940


Contacts
Contact: Hee-Soo Kim, professor +82-2-2072-3664 dami0605@snu.ac.kr

Locations
Korea, Republic of
Hee-Soo Kim Recruiting
Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
Contact: Hee-Soo Kim    1052878006    dami0605@snu.ac.kr   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Hee-Soo Kim, Phd    +82220723659    dami0605@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hee-Soo Kim, Professor Seoul National University Hospital

Responsible Party: Hee-Soo Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03540940     History of Changes
Other Study ID Numbers: H 1804-100-938
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No