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

• Sponsor: Kyungpook National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03524586
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 13.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Endotracheal; Airway Management	Procedure: Ipsilateral rotation of head; Procedure: Contralateral rotation of head	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Screening
• 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.
• Actual Study Start Date: Jan 2, 2018
• Actual Primary Completion Date: Apr 5, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ipsilateral rotation of head Head was laterally rotated to the same side against fixed tube	Procedure: Ipsilateral rotation of head; Ipsilateral rotation of head against fixed tube
Active Comparator: Contralateral rotation of head Head was laterally rotated to the opposite side against fixed tube	Procedure: Contralateral rotation of head; Contralateral rotation of head against fixed tube

Outcome Measures

Primary Outcome Measures

1. The endotracheal tube cuff pressure [During procedure]

   The endotracheal tube cuff pressure was checked using a manometer

Secondary Outcome Measures

1. The distance from the endotracheal tube tip to the carina [During procedure]

   The distance from the endotracheal tube tip to the carina was recorded again using a fiberoptic bronchoscope.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyungpook national university hospital	Daegu		Korea, Republic of	700-412

Sponsors and Collaborators

• Kyungpook National University Hospital

Investigators

• Principal Investigator: Saeyoung Kim, Kyungpook National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Saeyoung Kim, MD, PhD, Associate professor, Kyungpook National University Hospital
• ClinicalTrials.gov Identifier: NCT03524586
• Other Study ID Numbers: 2017-12-001-002
• First Posted: May 15, 2018
• Last Update Posted: May 17, 2018
• Last Verified: May 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 17, 2018