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

Cuff Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797938
• Other study ID #: KNUH 2016-02-017-001
• Status: Completed
• Phase: N/A
• First received: June 9, 2016
• Last updated: January 29, 2017
• Start date: June 2016
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cuff Pressure

Intervention

Device:
• Taper guard tube
Taper guard tube was intubated
• Cylindrical tube
Cylindrical tube was intubated

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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