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Comparison of the Cuff Pressure of TaperGuard and Cylindrical- Endotracheal Tube During Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT03040440
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Younghoon Jeon, Kyungpook National University Hospital

Study Description
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Brief Summary:
The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard endotracheal tube during laparoscopic cholecystectomy.

Condition or disease Intervention/treatment Phase
Cuff Pressure Device: Cylindrical endotracheal tube Device: TaperGaurd endotracheal tube Not Applicable

Detailed Description:
Sixty four participants were assigned to one of the two groups: cylindrical and TaperGuard endotracheal tube. At the supine position, cuff pressure of endotracheal tube was measured before and after abdominal insufflation in the supine position. After insufflation the head-up position (30°) was made and cuff pressure was recorded.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of the Cuff Pressure of TaperGuard Endotracheal Tube and Cylindrical- Endotracheal Tube During Laparoscopic Surgery
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 30, 2016
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cylindrical endotracheal tube
Cylindrical endotracheal tube was intubated in 32 participants
 Device: Cylindrical endotracheal tube
Cylindrical endotracheal tube was intubated
Experimental: TaperGuard endotracheal tube
TaperGuard endotracheal tube was intubated in 32 participants
 Device: TaperGaurd endotracheal tube
TaperGaurd endotracheal tube was intubated


Outcome Measures
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Primary Outcome Measures :
  1. cuff pressure [ Time Frame: 5 minutes after intubation ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who were underwent laparoscopic cholecystectomy with American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

  • history with respiratory disease, difficult intubation, and morbid obesity (body mass index more than 35 kg/m2).
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): NCT03040440


Locations
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Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
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Study Chair: Younghoon Jeon, MD Kyungpook National University Hospital
More Information
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Responsible Party: Younghoon Jeon, Professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT03040440    
Other Study ID Numbers: KNUH 2016-03-001-004
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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