NCT02797938

Brief Summary

Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. The change of cuff pressure was compared between two groups

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 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

June 9, 2016

Last Update Submit

January 29, 2017

Conditions

Cuff Pressure

Outcome Measures

Primary Outcomes (1)

  • Change of cuff pressure

    Change of cuff pressure of endotracheal tube after rotation 45 degree of head

    5 minutes after rotation of 45 degree of head

Study Arms (2)

Taper guard tube

EXPERIMENTAL

Taper guard tube was intubated in 26 patients

Device: Taper guard tube

Cylindrical tube

ACTIVE COMPARATOR

Cylindrical tube was intubated in 26 patients

Device: Cylindrical tube

Interventions

Taper guard tubeDEVICE

Taper guard tube was intubated

Taper guard tube
Cylindrical tubeDEVICE

Cylindrical tube was intubated

Cylindrical tube

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent middle ear surgery with general anesthesia American Society of Anesthesiology status 1-3

You may not qualify if:

  • Patient with neck pain Patient with a history of neck surgery Patient with limited movement of neck Patient with body mass index more than 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

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

June 9, 2016

First Posted

June 14, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Locations

KR(1)