Trial Outcomes & Findings for Comparison of Flexible Fibreoptic Scope With Pentax AWS Videolaryngoscope for Ease of Intubation During Awake Intubation (NCT NCT02614924)

NCT ID: NCT02614924

Last Updated: 2016-08-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: up to 20 minutes
• Results posted on: 2016-08-22

Participant Flow

Patients were recruited between 27.11.12 till 24.7.14. Recruitment was done during anaesthetic prep assessment.

No participants were excluded

Participant milestones

Measure	Flexible Fibre-optic Scope Randomly allocated to fibreoptic group Flexible fibreoptic scope: Patient intubated using fibreoptic scope	Pentax AWS Videolaryngoscope Randomly allocated to Pentax AWS
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Flexible Fibreoptic Scope With Pentax AWS Videolaryngoscope for Ease of Intubation During Awake Intubation

Baseline characteristics by cohort

Measure	Flexible Fibre-optic Scope n=20 Participants Randomly allocated to fibreoptic group Flexible fibreoptic scope: Patient intubated using fibreoptic scope	Pentax AWS Videolaryngoscope Group n=20 Participants Randomly allocated Pentax AWS videolaryngoscope and intubated using Pentax AWS videolaryngoscope	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	55.5 years n=5 Participants	66.5 years n=7 Participants	60.5 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United Kingdom	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 20 minutes

Outcome measures

Measure	Flexible Fibre-optic Scope n=20 Participants Randomly allocated to fibreoptic group Flexible fibreoptic scope: Patient intubated using fibreoptic scope	Pentax AWS Videolaryngoscope n=20 Participants randomly allocated to Pentax AWs
Total Time Taken to Complete the Procedure of Awake Intubation	900 seconds Interval 739.0 to 1059.0	651 seconds Interval 601.0 to 720.0

SECONDARY outcome

Timeframe: up to 10 minutes

Outcome measures

Measure	Flexible Fibre-optic Scope n=20 Participants Randomly allocated to fibreoptic group Flexible fibreoptic scope: Patient intubated using fibreoptic scope	Pentax AWS Videolaryngoscope n=20 Participants randomly allocated to Pentax AWs
Intubation Time	420 seconds Interval 283.0 to 480.0	183 seconds Interval 144.0 to 220.0

Adverse Events

Flexible Fibre-optic Scope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pentax AWS Videolaryngoscope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ratidzo Danha

UHCW NHS Trust

Phone: 02476 964000

Email: Ratidzo.Danha@uhcw.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place