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

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

Tracking Information

• First Submitted Date: January 31, 2017
• First Posted Date: February 2, 2017
• Last Update Posted Date: February 2, 2017
• Actual Study Start Date: June 1, 2016
• Actual Primary Completion Date: December 15, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 31, 2017): cuff pressure [ Time Frame: 5 minutes after intubation ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of the Cuff Pressure of TaperGuard and Cylindrical- Endotracheal Tube During Laparoscopic Surgery
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Other
• Condition: Cuff Pressure

Intervention

• Device: Cylindrical endotracheal tube
  Cylindrical endotracheal tube was intubated
• Device: TaperGaurd endotracheal tube
  TaperGaurd endotracheal tube was intubated

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2017): 64
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 30, 2016
• Actual Primary Completion Date: December 15, 2016 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03040440
• Other Study ID Numbers: 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

• Plan to Share IPD: Yes

• Responsible Party: Younghoon Jeon, Kyungpook National University Hospital
• Study Sponsor: Kyungpook National University Hospital
• Collaborators: Not Provided

Investigators

• Study Chair: Younghoon Jeon, MD; Kyungpook National University Hospital

• PRS Account: Kyungpook National University Hospital
• Verification Date: January 2017