Trial Outcomes & Findings for Standard Versus Flexible Tip Bougie for Videolaryngoscopy (NCT NCT04973176)

Results Overview

Composite score of difficulty of tracheal intubation using the bougie devices minimum score is zero, maximum possible score is 10, higher values represent worse outcome. Total score is sum of sub scales, values are numbers Total 6 sub scale from N1 to N6 ( N1: 0-2, N2: 0-1, N3:0-5, N4: 0-1, N5 0-1, N6 0-1, so total mIDS score is sum of N1 to N 6 sub scales)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

160 participants

Primary outcome timeframe

average 1 minute

Results posted on

2025-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter ) Standard Bougie: Standard Bougie for endotracheal intubation	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation
Overall Study STARTED	80	80
Overall Study COMPLETED	80	80
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie n=80 Participants Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter ) Standard Bougie: Standard Bougie for endotracheal intubation	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie n=80 Participants Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=80 Participants	0 Participants n=80 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=80 Participants	70 Participants n=80 Participants	139 Participants n=160 Participants
Age, Categorical >=65 years	11 Participants n=80 Participants	10 Participants n=80 Participants	21 Participants n=160 Participants
Age, Continuous	55.3 year STANDARD_DEVIATION 16.3 • n=80 Participants	55.2 year STANDARD_DEVIATION 16.1 • n=80 Participants	55.2 year STANDARD_DEVIATION 16.1 • n=160 Participants
Sex: Female, Male Female	40 Participants n=80 Participants	46 Participants n=80 Participants	86 Participants n=160 Participants
Sex: Female, Male Male	40 Participants n=80 Participants	34 Participants n=80 Participants	74 Participants n=160 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	80 participants n=80 Participants	80 participants n=80 Participants	160 participants n=160 Participants

PRIMARY outcome

Timeframe: average 1 minute

Composite score of difficulty of tracheal intubation using the bougie devices minimum score is zero, maximum possible score is 10, higher values represent worse outcome. Total score is sum of sub scales, values are numbers Total 6 sub scale from N1 to N6 ( N1: 0-2, N2: 0-1, N3:0-5, N4: 0-1, N5 0-1, N6 0-1, so total mIDS score is sum of N1 to N 6 sub scales)

Outcome measures

Outcome measures
Measure	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie n=80 Participants Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter ) Standard Bougie: Standard Bougie for endotracheal intubation	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie n=80 Participants Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation
Modified Intubation Difficulty Scale Score (mIDS)	1 score on a scale range of 0 to 10 number Interval 0.0 to 2.0	0 score on a scale range of 0 to 10 number Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: less than two minutes

Time from when the videolaryngoscope is introduced into the oral cavity until the first capnography waveform is obtained.

Outcome measures

Outcome measures
Measure	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie n=80 Participants Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter ) Standard Bougie: Standard Bougie for endotracheal intubation	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie n=80 Participants Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation
Time to Successful Tracheal Intubation	42.9 seconds Standard Deviation 9.1	41.0 seconds Standard Deviation 6.1

SECONDARY outcome

Timeframe: less than one minute

Time from when the videolaryngoscope is introduced into the oral cavity to best view of the glottis (vocal cords).

Outcome measures

Outcome measures
Measure	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie n=80 Participants Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter ) Standard Bougie: Standard Bougie for endotracheal intubation	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie n=80 Participants Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation
Laryngoscopy Time	5 seconds Standard Deviation 2	4.6 seconds Standard Deviation 1.7

SECONDARY outcome

Timeframe: average 1 minute

This is the percentage of patients being successfully intubated at the first attempt. This will be compared for two bougies

Outcome measures

Outcome measures
Measure	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie n=80 Participants Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter ) Standard Bougie: Standard Bougie for endotracheal intubation	Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie n=80 Participants Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK) Flexi-tip Bougie (P3 Medical Bristol,UK): Flexi-tip Bougie for endotracheal intubation
Overall First Attempt Success Rate	79 Participants	80 Participants

SECONDARY outcome

Timeframe: average 1 minute

Population: this data was not collected and therefore not analysed

This is scored between 0 to 10, 0 being easy to use and 10 being extremely difficult to use

Outcome measures

Outcome data not reported

Adverse Events

Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Standard Bougie

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Endotracheal Intubation With C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie

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 Cyprian Mendonnca

University Hospitals Coventry and Warwickshire NHS Trust

Phone: 02476964000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place