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Clinical Trials/NCT03524586
NCT03524586CompletedNot Applicable

Comparison of the Endotracheal Tube Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head During Tympanoplasty; Prospective Study.

Kyungpook National University Hospital1 site in 1 country52 target enrollmentStarted: January 2, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
1
Primary Endpoint
The endotracheal tube cuff pressure

Study Overview

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.

Detailed Description

The inflation of the endotracheal tube cuff is very useful to prevent aspiration of contaminated substances into lung past endotracheal tube and leakage of gas during positive pressure ventilation. However, excessive inflation of endotracheal tube cuff frequently causes tracheal mucosal damage, which can increase the incidence of sore throat, hoarseness, and coughing after surgery.

Taper-guard cuffed tube was newly developed. Taper-guard endotracheal tube is more effective in providing a sealing effect than a cylindrical endotracheal tube in an in vitro study. However, recently, it was reported that the cuff pressure of a Taper-guard endotracheal tube significantly increased after a positional change from the supine to the lateral flank position, compared to that of a cylindrical endotracheal tube. However, during tympanoplasty, the investigators need to rotate head for proper position.

In this study, therefore, the investigators investigate the difference of the endotracheal tube cuff pressure of a taper-guard cuffed tube between ipsilateral and contralateral rotation of head against the fixed tube during tympanoplasty.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Ipsilateral rotation of head

Experimental

Head was laterally rotated to the same side against fixed tube

Intervention: Ipsilateral rotation of head (Procedure)

Contralateral rotation of head

Active Comparator

Head was laterally rotated to the opposite side against fixed tube

Intervention: Contralateral rotation of head (Procedure)

Outcomes

Primary Outcomes

The endotracheal tube cuff pressure

Time Frame: During procedure

The endotracheal tube cuff pressure was checked using a manometer

Secondary Outcomes

  • The distance from the endotracheal tube tip to the carina(During procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Saeyoung Kim, MD, PhD

Associate professor

Kyungpook National University Hospital

Study Sites (1)

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