NCT02949856

Brief Summary

This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck. Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

October 20, 2016

Last Update Submit

October 27, 2016

Conditions

Thyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Change in intracuff pressure

    1 year

Secondary Outcomes (1)

  • Change in distance from carina to tip of tube

    1 year

Study Arms (2)

Tapered

EXPERIMENTAL

Mallinckrodt, COVIDIEN

Device: Mallinckrodt, COVIDIEN

Cylindrical

ACTIVE COMPARATOR

Endotracheal tube, Unomedical

Device: Endotracheal tube, Unomedica

Interventions

Mallinckrodt, COVIDIENDEVICE
Tapered
Endotracheal tube, UnomedicaDEVICE
Cylindrical

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy

You may not qualify if:

  • difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yong-Cheol Lee, MD, PhD

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Cheol Lee, MD, PhD

CONTACT

82-53-250-7193yclee@dsmc.or.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 31, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share