Clinical trial NCT02666300: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications
Keywords: Postoperative sore throat,Anesthesia
Lead sponsor: The Second Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The incidence and severity of Participants with TaperGuard ETT at 0,1,,6,12,24 hours post-operative
timeFrame: 0,1,,6,12,24 hours post-operative
measure: The incidence and severity of Participants with Cylindrical ETT at 0,1,,6,12,24 hours post-operative
timeFrame: 0,1,,6,12,24 hours post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: The Second Affiliated Hospital of Dalian Medical University
name: Xiao Z Yang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: