NCT03887897

Brief Summary

In recent decades, numerous videolaryngoscopes have been introduced to facilitate tracheal intubation. However, it remains unclear whether videolaryngoscope will increase the successful tracheal intubation compared with usual Macintosch laryngoscope. Therefore, this pilot study is a randomized controlled trial designed to compare the first-pass intubation success of the Airtraq laryngoscope versus the Macintosh direct laryngoscope in patients requiring general anesthesia for elective operation, with the aims to examine the feasibility of a large multicentre effectiveness trial by assessing recruitment targets, testing the data completeness, and local incidence of first-pass intubation success.

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
1,586

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration 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

First Submitted

Initial submission to the registry

March 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 2, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

3.2 years

First QC Date

March 20, 2019

Last Update Submit

November 7, 2019

Conditions

Intubation

Keywords

First-pass; first attempt;intubation success

Outcome Measures

Primary Outcomes (1)

  • First-pass success in tracheal intubation

    Successful tracheal intubation during the first attempt, confirmed by EtCO2 tracing

    During tracheal intubation procedure

Secondary Outcomes (5)

  • Time to successful tracheal intubation

    During tracheal intubation procedure

  • Hoarseness

    At 48 hours after operation

  • Sore throat

    At 48 hours after operation

  • Use of adjuncts during tracheal intubation

    During tracheal intubation procedure

  • Requirement of additional maneuvers

    During tracheal intubation procedure

Study Arms (2)

Airtraq

ACTIVE COMPARATOR

Airtraq laryngoscope

Procedure: Tracheal Intubation

Macintosh

ACTIVE COMPARATOR

Macintosh laryngoscope

Procedure: Tracheal Intubation

Interventions

Tracheal IntubationPROCEDURE

Tracheal intubation performed by attending anesthesiologists using either Airtraq laryngoscope or Macintosh laryngoscope

AirtraqMacintosh

Eligibility Criteria

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

You may qualify if:

  • adult (\>18years) patients;
  • receiving general anaesthesia that requires tracheal intubation

You may not qualify if:

  • known or predicted difficult bag-mask ventilation
  • patients scheduled for (awake or asleep) fibreoptic intubation
  • patients requiring rapid sequence intubation
  • language or congnitive problems that preclude adequate informed consent being obtained
  • patient or anaesthetist refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia and Intensive Care, New Territories West Cluster, Hospital Authority

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Mihai R, Blair E, Kay H, Cook TM. A quantitative review and meta-analysis of performance of non-standard laryngoscopes and rigid fibreoptic intubation aids. Anaesthesia. 2008 Jul;63(7):745-60. doi: 10.1111/j.1365-2044.2008.05489.x.

    PMID: 18582261BACKGROUND

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Mathew TV Chan, MBBS

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew TV Chan, MBBS

CONTACT

+852 91363821mtvchan@cuhk.edu.hk

Carmen KM Lam, MBBS

CONTACT

+852 90804633carmenlam1013@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 25, 2019

Study Start

October 2, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

November 12, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)