NCT04503031

Brief Summary

This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during oral surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

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

January 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

August 3, 2020

Last Update Submit

October 26, 2020

Conditions

Endotracheal TubeCuff Pressure

Outcome Measures

Primary Outcomes (1)

  • Cuff pressure

    Cuff pressure is measured with a manometer (Mallinckrodt Medical, Hennef, Germany).

    5 minutes after change of head position

Study Arms (2)

cylindrical tube group

ACTIVE COMPARATOR

The patient in cylindrical tube group (n=26) were intubated with cylindrical shaped endotracheal tube.

Device: cylindrical endotracheal tube

tapergaurd tube group

EXPERIMENTAL

The patient in taperguard tube group (n=26) was intubated with TaperGuard endotracheal tube.

Device: TaperGuard endotracheal tube

Interventions

TaperGuard endotracheal tubeDEVICE

TaperGuard endotracheal tube is intubated

tapergaurd tube group
cylindrical endotracheal tubeDEVICE

endotracheal tube is intubated

cylindrical tube group

Eligibility Criteria

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

You may qualify if:

  • Patient who were underwent nasal intubation

You may not qualify if:

  • history of difficult intubation, limited neck movement, respiratory diseases and 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, Mr

    kyungook national university hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 6, 2020

Study Start

January 10, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)