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

R

rehab zayed

Status

Unknown

Conditions

Difficult Intubation
Difficult Mask Ventilation

Treatments

Device: flexible fibreoptic bronchoscope
Device: C-MAC VS

Study type

Interventional

Funder types

Other

Identifiers

NCT04759287
0304792

Details and patient eligibility

About

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

Full description

C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

VS group
Active Comparator group
Description:
include patients undergoing awake intubation using the C-MAC VS
Treatment:
Device: C-MAC VS
FOB group
Placebo Comparator group
Description:
will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.
Treatment:
Device: flexible fibreoptic bronchoscope

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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