Comparison of the Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head

Not Applicable

Completed

• Conditions: Airway Management; Anesthesia, Endotracheal
• Interventions: Procedure: Contralateral rotation of head; Procedure: Ipsilateral rotation of head

• Registration Number: NCT03524586
• Lead Sponsor: Kyungpook National University Hospital

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 Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-04-05
• Status Verified: 2018-05
• Study Completion: 2018-05-01
• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-02
• Last Update Submitted: 2018-05-14
• Study First Posted: 2018-05-15
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contralateral rotation of head	Contralateral rotation of head	Head was laterally rotated to the opposite side against fixed tube
Ipsilateral rotation of head	Ipsilateral rotation of head	Head was laterally rotated to the same side against fixed tube

Primary Outcome Measures

Name	Time	Method
The endotracheal tube cuff pressure	During procedure	The endotracheal tube cuff pressure was checked using a manometer

Secondary Outcome Measures

Name	Time	Method
The distance from the endotracheal tube tip to the carina	During procedure	The distance from the endotracheal tube tip to the carina was recorded again using a fiberoptic bronchoscope.

Trial Locations

Locations (1)

Kyungpook national university hospital; 🇰🇷 Daegu, Korea, Republic of