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

Primary Purpose

Intubation, Pain, Pharyngitis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Barrel
Tapered
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intubation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Barrel

Tapered

Arm Description

Endotracheal tube with barrel-shaped cuff will be used during general anesthesia.

Endotracheal tube with tapered-shaped cuff will be used during general anesthesia.

Outcomes

Primary Outcome Measures

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®.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 27, 2014
Last Updated
June 13, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02165319
Brief Title
The Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change
Acronym
LateralCuff
Official Title
Comparison of the Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change: Barrel-shaped vs. Taper-shaped Cuff
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation, Pain, Pharyngitis, Hoarseness, Cough

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Barrel
Arm Type
Active Comparator
Arm Description
Endotracheal tube with barrel-shaped cuff will be used during general anesthesia.
Arm Title
Tapered
Arm Type
Active Comparator
Arm Description
Endotracheal tube with tapered-shaped cuff will be used during general anesthesia.
Intervention Type
Device
Intervention Name(s)
Barrel
Intervention Description
Barrel-shaped endotracheal tube will be used during general anesthesia.
Intervention Type
Device
Intervention Name(s)
Tapered
Intervention Description
Tapered-shaped tube will be used during general anesthesia.
Primary Outcome Measure Information:
Title
The cuff pressure after supine-to-lateral position change
Description
The cuff pressure will be measured after supine-to-lateral position change using the Manometer Portex®.
Time Frame
At 10 minutes after anesthetic induction
Secondary Outcome Measure Information:
Title
The distance from the tube to the carina
Description
The distance from the tube to the carina will be measured using bronchoscopy after supine-to-lateral position change.
Time Frame
At 10 minutes after anesthetic induction
Title
Complications related to endotracheal tube
Description
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.
Time Frame
At 0, 2, and 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Chang Kim, MD
Phone
+821028862876
Email
onidori1979@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Pyoung Park, PhD
Organizational Affiliation
Seoul National University of Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee-Pyoung Park, PhD
Phone
82-2-2072-2365
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyun-Chang Kim, MD
First Name & Middle Initial & Last Name & Degree
Hee-Pyoung Park, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25894912
Citation
Kim HC, Lee YH, Kim E, Oh EA, Jeon YT, Park HP. Comparison of the endotracheal tube cuff pressure between a tapered- versus a cylindrical-shaped cuff after changing from the supine to the lateral flank position. Can J Anaesth. 2015 Oct;62(10):1063-70. doi: 10.1007/s12630-015-0394-z. Epub 2015 Apr 17.
Results Reference
derived

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

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