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

Postoperative Complications Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02666300
• Other study ID #: post2015taper
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2016
• Last updated: January 24, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2016
• Source: The Second Affiliated Hospital of Dalian Medical University
• Contact: Xiao zhao Yang, MD,PhD
• Phone: 0866-17709873399
• Email: 524798465[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• General anesthesia surgery

aged 18 to 75 years

ASA class? or ?

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Other:
• TaperGuard ETT
tracheal intubation with TaperGuard ETT

Locations

Country	Name	City	State
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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