NCT02666300

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

January 18, 2016

Last Update Submit

January 24, 2016

Conditions

Postoperative Complications

Keywords

Postoperative sore throat,Anesthesia

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

TaperGuard ETT

EXPERIMENTAL

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

Other: TaperGuard ETT

Interventions

TaperGuard ETTOTHER

tracheal intubation with TaperGuard ETT

TaperGuard ETT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiao Z Yang, MD,PhD

    The Second Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao zhao Yang, MD,PhD

CONTACT

0866-17709873399524798465@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 28, 2016

Study Start

December 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

CN(1)