NCT02210338

Brief Summary

The study aims to determine the better device to facilitate intubation in patients with a limited neck movement and small mouth opening. This may help anesthesiology as well as emergency medicine practitioners and departments to decide when choosing between these two conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior when compared to the Bonfils Intubation Fibrescope in success of intubation, time to intubation and complication rate in patients with a fixed cervical collar.

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
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

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

Study Start

First participant enrolled

August 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

August 5, 2014

Last Update Submit

April 27, 2016

Conditions

IntubationAirway

Outcome Measures

Primary Outcomes (1)

  • Success of intubation on first attempt

    A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Intubation will then proceed with the assigned airway device. A successful outcome at intubation will involve being able to pass an appropriately sized endotracheal tube pass the vocal cords into the trachea on the first try, as evidenced by the presence of end tidal carbon dioxide on a capnograph.

    up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at intubation

Secondary Outcomes (1)

  • Time taken to successful intubation

    up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after successful intubation

Study Arms (2)

Karl Storz C-MAC

EXPERIMENTAL

Intubation of patient using the Karl Storz C-MAC video laryngoscope

Device: Karl Storz C-MAC

Bonfils Intubation Fibrescope

EXPERIMENTAL

Intubation of patient using Bonfils Intubation Fibrescope

Device: Bonfils Intubation Fibrescope

Interventions

Karl Storz C-MACDEVICE
Karl Storz C-MAC
Bonfils Intubation FibrescopeDEVICE
Bonfils Intubation Fibrescope

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective surgery under general anaesthesia who require endotracheal intubation

You may not qualify if:

  • Patients with history of previous difficult endotracheal intubation
  • Patients with two or more predictors of difficult mask ventilation or difficult intubation or the combination of both
  • Patients with ASA (American Society of Anesthesiologists) grading of III and above are excluded from the study, as well as patients with 2 or more predictors for difficult mask ventilation or difficult intubation or the combination of both.
  • Patients needing a rapid sequence induction for rapid securement of the airway
  • Pregnant women
  • Patients below the age of 21 years old
  • Patients unfit to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore, 169608, Singapore

RECRUITING

Related Publications (1)

  • Abdullah HR, Li-Ming T, Marriott A, Wong TG. A comparison between the Bonfils Intubation Fiberscope and McCoy laryngoscope for tracheal intubation in patients with a simulated difficult airway. Anesth Analg. 2013 Nov;117(5):1217-20. doi: 10.1213/ANE.0b013e3182a46fa9.

    PMID: 24029854BACKGROUND

Study Officials

  • Theodore GL Wong

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodore GL Wong

CONTACT

+6598203675theodore.wong.g.l@sgh.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 6, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

SG(1)