Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation

NCT04759287 | Unknown

• 1 other identifier: 0304792
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

C-MAC- Video Stylet is a completely new type of video endoscope. It combines the advantages of both rigid and flexible intubation endoscopes.

Conditions

Difficult Mask Ventilation; Difficult Intubation

Outcome Measures

Primary Outcomes (1)

• the time required for a wake intubation

  assess the time required for a wake intubation using C-MAC VS versus FOB in patients with anticipated difficult airway.

  10 minutes

Study Arms (2)

VS group

ACTIVE COMPARATOR

include patients undergoing awake intubation using the C-MAC VS

Device: C-MAC VS

FOB group

PLACEBO COMPARATOR

will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.

Device: flexible fibreoptic bronchoscope

Interventions

C-MAC VS DEVICE

The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS

VS group

flexible fibreoptic bronchoscope DEVICE

The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.

FOB group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with BMI ≥ 30 kg/m2,
• presence of any predictors of difficult intubation;
• Mallampati score \> =3;
• inter-incisor distance \< 3 cm;
• thyromental distance \< 6 cm;
• neck extension \< 80°from neck flexion;
• cervical spine instability;
• history of difficult endotracheal intubation or difficult mask ventilation

You may not qualify if:

• patients have increased risk of pulmonary aspiration;
• have significant medical diseases in term of cardiac, respiratory, hepatic, renal,

Sponsors & Collaborators

• rehab zayed: lead

Study Sites (1)

rehab Abd Elaziz

Alexandria, 000000, Egypt

Location

Study Officials

• rehab A. Abd Elaziz, Ass.Prof.

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisstant Professor of Anesthesia

Model Details: The patients will be randomly assigned into two equal groups using computer-generated randomization technique. The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS. The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: November 20, 2020
• Primary Completion: May 20, 2021
• Study Completion: June 1, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

EG (1)