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To Compare the Incidence of POST Between a TaperGuard ETT and Cylindrical-shaped ETT Under High Cuff Pressure

Primary Purpose

Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TaperGuard ETT
Sponsored by
The Second Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Complications focused on measuring Postoperative sore throat,Anesthesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • General anesthesia surgery

aged 18 to 75 years

ASA classⅠ or Ⅱ

undergoing elective non-throat and non-neck surgery under generalanesthesia

intubation timemore than two hours

BMI≤30 kg/m2

Exclusion Criteria:

  • Patients with ahistory of preoperative sore throat

known airway disease and difficult intubation

more than one attempt at intubation

Mallampati grade 3 to 4

Cormack-Lehane grade3 to 4

BMI >35 Kg/m2

Those have an operation with the lateral flank or prone position

Sites / Locations

  • The Second Hospital of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TaperGuard ETT

Arm Description

tracheal intubation with the TaperGuard ETT,the ETT cuff is Taper-shangped.

Outcomes

Primary Outcome Measures

The incidence and severity of Participants with TaperGuard ETT at 0,1,,6,12,24 hours post-operative
The incidence and severity of Participants with Cylindrical ETT at 0,1,,6,12,24 hours post-operative

Secondary Outcome Measures

Full Information

First Posted
January 18, 2016
Last Updated
January 24, 2016
Sponsor
The Second Affiliated Hospital of Dalian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02666300
Brief Title
To Compare the Incidence of POST Between a TaperGuard ETT and Cylindrical-shaped ETT Under High Cuff Pressure
Official Title
To Compare the Incidence of Postoperative Sore Throat Between a TaperGuardEndotracheal Tube(ETT)and a Cylindrical-shaped ETT Under Highcuffpressure:A Randomized,Double-blindTrial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Dalian Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Whether the new type of ETT(TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure.
Detailed Description
BACKGROUND:Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Endotracheal tube size ,airway manipulation ,patients position et al. have been recognized as the factors affecting Postoperative Sore Throat .Controversy in respect of the relationship between the cuff design and POST is still existed. Whether the new type of ETT (TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure. METHODS:Patients undergoing elective non-throat and non-neck surgery were randomly allocated to receive either a TaperGuard ETT(group T) or Cylindrical-shaped ETT ( Group C).Patients received general anesthesia with different endotracheal tubes .Recoil of inflation syringe plunger was used to inflate the cuff. In the study , the cuff pressures of the endotracheal tube were recorded by a calibrated cuff manometer at two time: when the intubation was complited and before endotracheal tube was removed. The incidence and severity of Postoperative Sore Throat(POST),hoarseness, cough were collected by a single investigator blinded to the experiment at 0, 1,6, 12, and 24 hours post-operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Postoperative sore throat,Anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TaperGuard ETT
Arm Type
Experimental
Arm Description
tracheal intubation with the TaperGuard ETT,the ETT cuff is Taper-shangped.
Intervention Type
Other
Intervention Name(s)
TaperGuard ETT
Intervention Description
tracheal intubation with TaperGuard ETT
Primary Outcome Measure Information:
Title
The incidence and severity of Participants with TaperGuard ETT at 0,1,,6,12,24 hours post-operative
Time Frame
0,1,,6,12,24 hours post-operative
Title
The incidence and severity of Participants with Cylindrical ETT at 0,1,,6,12,24 hours post-operative
Time Frame
0,1,,6,12,24 hours post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: General anesthesia surgery aged 18 to 75 years ASA classⅠ or Ⅱ undergoing elective non-throat and non-neck surgery under generalanesthesia intubation timemore than two hours BMI≤30 kg/m2 Exclusion Criteria: Patients with ahistory of preoperative sore throat known airway disease and difficult intubation more than one attempt at intubation Mallampati grade 3 to 4 Cormack-Lehane grade3 to 4 BMI >35 Kg/m2 Those have an operation with the lateral flank or prone position
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao zhao Yang, MD,PhD
Phone
0866-17709873399
Ext
0866
Email
524798465@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Z Yang, MD,PhD
Organizational Affiliation
The Second Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Z yang, MD,PhD
Phone
0866-17709873399

12. IPD Sharing Statement

Learn more about this trial

To Compare the Incidence of POST Between a TaperGuard ETT and Cylindrical-shaped ETT Under High Cuff Pressure

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