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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02666300

Enrollment

Registered

2016-01-28

Start date

2015-12-31

Completion date

2016-02-29

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

Postoperative sore throat,Anesthesia

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.

Interventions

OTHERTaperGuard ETT

tracheal intubation with TaperGuard ETT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Countries

China

Contacts

Primary ContactXiao zhao Yang, MD,PhD

524798465@qq.com0866-17709873399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026