NCT02614924

Brief Summary

The purpose of this study is to identify whether Pentax Airway Scope (AWS) videolaryngoscope would be a more effective device compared to flexible fibreoptic scope (FOS) for awake intubation in a difficult airway.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Status
completed

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

November 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 22, 2016

Completed
Last Updated

August 22, 2016

Status Verified

July 1, 2016

Enrollment Period

1.7 years

First QC Date

November 24, 2015

Results QC Date

March 16, 2016

Last Update Submit

July 12, 2016

Conditions

Anesthesia Intubation Complication

Outcome Measures

Primary Outcomes (1)

  • Total Time Taken to Complete the Procedure of Awake Intubation

    up to 20 minutes

Secondary Outcomes (1)

  • Intubation Time

    up to 10 minutes

Study Arms (2)

Flexible fibre-optic scope

OTHER

Randomly allocated to fibreoptic group

Device: Flexible fibreoptic scopeDevice: Pentax AWS videolaryngoscope

Pentax AWS videolaryngoscope

OTHER

Randomly allocated Pentax AWS videolaryngoscope

Device: Flexible fibreoptic scopeDevice: Pentax AWS videolaryngoscope

Interventions

Flexible fibreoptic scopeDEVICE

Patient intubated using fibreoptic scope

Flexible fibre-optic scopePentax AWS videolaryngoscope
Pentax AWS videolaryngoscopeDEVICE

Patient intubated using Pentax AWS videolaryngoscope

Flexible fibre-optic scopePentax AWS videolaryngoscope

Eligibility Criteria

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

You may qualify if:

  • Patients with cervical spine disease presenting for cervical spinal surgery and requiring awake intubation under local anaesthesia and conscious sedation.
  • Patients with anticipated difficult airway include those with Mallampati class 3 and above, other signs such as limited neck movement and limited jaw protrusion will be include in the study

You may not qualify if:

  • Children below 18 years of age, pregnant mothers and patients presenting with airway pathology will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Dr Ratidzo Danha
Organization
UHCW NHS Trust
Ratidzo.Danha@uhcw.nhs.uk
02476 964000

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 25, 2015

Study Start

November 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 22, 2016

Results First Posted

August 22, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share