NCT03040440

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

January 31, 2017

Last Update Submit

January 31, 2017

Conditions

Cuff Pressure

Outcome Measures

Primary Outcomes (1)

  • cuff pressure

    5 minutes after intubation

Study Arms (2)

Cylindrical endotracheal tube

ACTIVE COMPARATOR

Cylindrical endotracheal tube was intubated in 32 participants

Device: Cylindrical endotracheal tube

TaperGuard endotracheal tube

EXPERIMENTAL

TaperGuard endotracheal tube was intubated in 32 participants

Device: TaperGaurd endotracheal tube

Interventions

Cylindrical endotracheal tubeDEVICE

Cylindrical endotracheal tube was intubated

Cylindrical endotracheal tube
TaperGaurd endotracheal tubeDEVICE

TaperGaurd endotracheal tube was intubated

TaperGuard endotracheal tube

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Study Officials

  • Younghoon Jeon, MD

    Kyungpook National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 2, 2017

Study Start

June 1, 2016

Primary Completion

December 15, 2016

Study Completion

December 30, 2016

Last Updated

February 2, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Locations

KR(1)