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NCT03524586 Clinical Trial

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

Airway Management Clinical Trial

Official title:
Comparison of the Endotracheal Tube Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head During Tympanoplasty; Prospective Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03524586
Other study ID # 2017-12-001-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2018
Est. completion date May 1, 2018

Study information
Verified date May 2018
Source Kyungpook National University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date May 1, 2018
Est. primary completion date April 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Ipsilateral rotation of head
Ipsilateral rotation of head against fixed tube
• Contralateral rotation of head
Contralateral rotation of head against fixed tube

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 The endotracheal tube cuff pressure The endotracheal tube cuff pressure was checked using a manometer During procedure
Secondary The distance from the endotracheal tube tip to the carina The distance from the endotracheal tube tip to the carina was recorded again using a fiberoptic bronchoscope. During procedure
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