The Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change

Pain Clinical Trial

— LateralCuff  

Official title:

Comparison of the Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change: Barrel-shaped vs. Taper-shaped Cuff

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02165319
• Other study ID #: LateralTaperedCuff-phpkhc
• Secondary ID: LateralCuff_SNUH
• Status: Not yet recruiting
• Phase: N/A
• First received: May 27, 2014
• Last updated: June 13, 2014
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2014
• Source: Seoul National University Hospital
• Contact: Hyun-Chang Kim, MD
• Phone: +821028862876
• Email: onidori1979[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff

Description:

The position of endotracheal tubes depends on the position of the patients. The change of the tube's position is known to influence the pressure of tube's cuff. The shape of the cuff (barrel-shaped versus tapered-shaped) may affect the tube's migration degree because of the difference of the frictional force.

The investigator try to compare the the cuff pressure after supine-to-lateral position change between barrel-shaped cuff and taper-shaped cuff.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient scheduled for nephrectomy in lateral decubitus position

Exclusion Criteria:

• Pregnancy

• Patients with difficult airway

• Patients with neck motion disorder

• Patients with history of neck surgery

• Patients with history of oral and pharyngeal surgery

• Patients with body mass index > 35

• Patients without teeth

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cough
• Hoarseness
• Intubation
• Pain
• Pharyngitis

Intervention

Device:
• Barrel
Barrel-shaped endotracheal tube will be used during general anesthesia.
• Tapered
Tapered-shaped tube will be used during general anesthesia.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cuff pressure after supine-to-lateral position change	The cuff pressure will be measured after supine-to-lateral position change using the Manometer Portex®.	At 10 minutes after anesthetic induction	Yes
Secondary	The distance from the tube to the carina	The distance from the tube to the carina will be measured using bronchoscopy after supine-to-lateral position change.	At 10 minutes after anesthetic induction	No
Secondary	Complications related to endotracheal tube	Complications related to endotracheal tube (sore throat, hoarseness, dysphagia and cough) will be measured as 0:none, 1:mild, 2:moderate, 3:severe at 0, 2, and 24 hours postoperatively.	At 0, 2, and 24 hours postoperatively	Yes