Standard Versus Flexible Tip Bougie for Videolaryngoscopy

NCT04973176 | Completed Results

• 1 other identifier: CM538321
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the flexible tip bougie with standard bougie for tracheal intubation using non channelled, acute angled video laryngoscope using modified intubation difficulty scale score as primary outcome.

Conditions

Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

• Modified Intubation Difficulty Scale Score (mIDS)

  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)

  average 1 minute

Secondary Outcomes (4)

• Time to Successful Tracheal Intubation

  less than two minutes

• Laryngoscopy Time

  less than one minute

• Overall First Attempt Success Rate

  average 1 minute

• Anaesthetist's Visual Analogue Score for Ease of Use of the Bougie

  average 1 minute

Study Arms (2)

Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Standard Bougie

ACTIVE COMPARATOR

Patients randomised to standard bougie will be intubated using standard bougie (Frova® airway intubation catheter )

Device: Standard Bougie

Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie

ACTIVE COMPARATOR

Patients randomised to Flexi-tio bougie will be intubated using Flexi-tip bougie (P3 medical Ltd, Bristol, UK)

Device: Flexi-tip Bougie (P3 Medical Bristol,UK)

Interventions

Standard Bougie DEVICE

Standard Bougie for endotracheal intubation

Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Standard Bougie

Flexi-tip Bougie (P3 Medical Bristol,UK) DEVICE

Flexi-tip Bougie for endotracheal intubation

Endotracheal intubation with C-MAC D Blade Videolaryngoscopy and Flexi-tip Bougie

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients aged above 18, presenting for elective surgical procedures and requiring general anaesthesia tracheal intubation.

You may not qualify if:

• Patients who are do not want to take part or do not give consent
• Patients below 18 years of age
• Patient physical status of ASA 4 and 5,
• Patients deemed to require awake intubation

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Results Point of Contact

• Title: Dr Cyprian Mendonnca
• Organization: University Hospitals Coventry and Warwickshire NHS Trust

cyprian.mendonca@uhcw.nhs.uk

02476964000

Study Officials

• Cyprian Mendonca, Phd, MD FRCA

  University Hospitals Coventry & Warwickshire NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 22, 2021
• Study Start: August 23, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)