NCT03524586

Brief Summary

This study evaluates the endotracheal tube cuff pressure of a taper-guard cuffed tube during tympanoplasty with ipsilateral rotation of head, compared to the contralateral rotation of head. The investigators will performed the ipsilateral rotation of head against the fixed tube in half of participants or the contralateral rotation of head in the other half.

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 2018

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

January 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

May 2, 2018

Last Update Submit

May 14, 2018

Conditions

Anesthesia, EndotrachealAirway Management

Outcome Measures

Primary Outcomes (1)

  • The endotracheal tube cuff pressure

    The endotracheal tube cuff pressure was checked using a manometer

    During procedure

Secondary Outcomes (1)

  • The distance from the endotracheal tube tip to the carina

    During procedure

Study Arms (2)

Ipsilateral rotation of head

EXPERIMENTAL

Head was laterally rotated to the same side against fixed tube

Procedure: Ipsilateral rotation of head

Contralateral rotation of head

ACTIVE COMPARATOR

Head was laterally rotated to the opposite side against fixed tube

Procedure: Contralateral rotation of head

Interventions

Ipsilateral rotation of headPROCEDURE

Ipsilateral rotation of head against fixed tube

Ipsilateral rotation of head
Contralateral rotation of headPROCEDURE

Contralateral rotation of head against fixed tube

Contralateral rotation of head

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists physical status classification I-III for a tympanoplasty under general anesthesia

You may not qualify if:

  • history of difficult intubation, limited neck movement, respiratory diseases, and body mass index \>35kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook national university hospital

Daegu, 700-412, South Korea

Location

Study Officials

  • Saeyoung Kim

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 15, 2018

Study Start

January 2, 2018

Primary Completion

April 5, 2018

Study Completion

May 1, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

KR(1)