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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Endotracheal Tube Cuff Pressure Between a Taper-guard Cuffed Tube and a Cylindrical-shaped Cuffed Tube After Changing in Position During Middle Ear Surgery

Conditions
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Cuff Pressure

Intervention / Treatment
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* Device: Taper guard tube
* Device: Cylindrical tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taper guard tube<br>Taper guard tube was intubated in 26 patients | Device: Taper guard tube<br>* Taper guard tube was intubated<br>|
| Active Comparator: Cylindrical tube<br>Cylindrical tube was intubated in 26 patients | Device: Cylindrical tube<br>* Cylindrical tube was intubated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |