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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

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date February 2, 2017
Actual Study Start Date  ICMJE June 1, 2016
Actual Primary Completion Date December 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
cuff pressure [ Time Frame: 5 minutes after intubation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Cuff Pressure of TaperGuard and Cylindrical- Endotracheal Tube During Laparoscopic Surgery
Official Title  ICMJE Comparison of the Cuff Pressure of TaperGuard Endotracheal Tube and Cylindrical- Endotracheal Tube During Laparoscopic Surgery
Brief Summary The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard endotracheal tube during laparoscopic cholecystectomy.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Cuff Pressure
Intervention  ICMJE
  • Device: Cylindrical endotracheal tube
    Cylindrical endotracheal tube was intubated
  • Device: TaperGaurd endotracheal tube
    TaperGaurd endotracheal tube was intubated
Study Arms  ICMJE
  • Active Comparator: Cylindrical endotracheal tube
    Cylindrical endotracheal tube was intubated in 32 participants
    Intervention: Device: Cylindrical endotracheal tube
  • Experimental: TaperGuard endotracheal tube
    TaperGuard endotracheal tube was intubated in 32 participants
    Intervention: Device: TaperGaurd endotracheal tube
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2017)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2016
Actual Primary Completion Date December 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03040440
Other Study ID Numbers  ICMJE KNUH 2016-03-001-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Younghoon Jeon, Kyungpook National University Hospital
Study Sponsor  ICMJE Kyungpook National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Younghoon Jeon, MD Kyungpook National University Hospital
PRS Account Kyungpook National University Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP