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

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ClinicalTrials.gov Identifier: NCT02797938
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Younghoon Jeon, Kyungpook National University

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

Condition or disease Intervention/treatment Phase
Cuff Pressure Device: Taper guard tube Device: Cylindrical tube Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Study Start Date : June 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Taper guard tube
Taper guard tube was intubated in 26 patients
Device: Taper guard tube
Taper guard tube was intubated

Active Comparator: Cylindrical tube
Cylindrical tube was intubated in 26 patients
Device: Cylindrical tube
Cylindrical tube was intubated




Primary Outcome Measures :
  1. Change of cuff pressure [ Time Frame: 5 minutes after rotation of 45 degree of head ]
    Change of cuff pressure of endotracheal tube after rotation 45 degree of head



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797938


Locations
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Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University

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Responsible Party: Younghoon Jeon, Professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT02797938     History of Changes
Other Study ID Numbers: KNUH 2016-02-017-001
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes