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

Study Overview
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Brief Summary
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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
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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.

Official Title
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To Compare the Incidence of Postoperative Sore Throat Between a TaperGuardEndotracheal Tube(ETT)and a Cylindrical-shaped ETT Under Highcuffpressure:A Randomized,Double-blindTrial.

Conditions
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Postoperative Complications

Intervention / Treatment
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* Other: TaperGuard ETT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TaperGuard ETT<br>tracheal intubation with the TaperGuard ETT，the ETT cuff is Taper-shangped. | Other: TaperGuard ETT<br>* tracheal intubation with TaperGuard ETT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of Participants with TaperGuard ETT at 0,1,,6,12,24 hours post-operative |  | 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 |  | 0,1,,6,12,24 hours post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative sore throat,Anesthesia