Comparison of the Cuff Pressure Between a Taper-guard Cuffed Tube and a Cylindrical-shaped Cuffed Tube

Not Applicable

Completed

• Conditions: Cuff Pressure
• Interventions: Device: Cylindrical tube; Device: Taper guard tube

• Registration Number: NCT02797938
• Lead Sponsor: Kyungpook National University Hospital

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

Detailed Description

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/O2 and remifentanil. The cuff pressure was initially set at 24 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. In addition, sore throat, hoarseness , dysphagia and cough were recorded 0, 6, 12, 24 hr after surgery. The change of cuff pressure was compared between two groups. The side effects associated with tube were compared between two groups.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-29
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cylindrical tube	Cylindrical tube	Cylindrical tube was intubated in 26 patients
Taper guard tube	Taper guard tube	Taper guard tube was intubated in 26 patients

Primary Outcome Measures

Name	Time	Method
Change of cuff pressure	5 minutes after rotation of 45 degree of head	Change of cuff pressure of endotracheal tube after rotation 45 degree of head

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of