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C-MAC Video Laryngoscope and VS-CMAC Fiberoptic Stylet for Awake Endoscopic Intubation in Predicted Difficult Airways

NCT04532138 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-08-31

No results posted yet for this study

Summary

An Anticipated difficult tracheal intubation is recommended to be managed performing the so called "Awake tracheal endoscopic intubation" (ATI) with the maintenance of patient's spontaneous breathing after an adequate sedation and topical anesthesia of upper airways, providing supplemental oxygen.

Initially only flexible bronchoscope was considered the device of choice (the gold standard) for ATI but in the last decade videolaryngoscopes with hyper-angulated blade have been demonstrated to be an efficacy technique.

Most recently, endoscopic rigid stylets such as Bonfils (Carl Storz™) and Sensacope (Acoutronic™) have been proposed as alternative techniques for ATI in the event of expected difficult tracheal intubation.

However, to date, no comparison studies have been carried out between these two kind of devices, alternative to flexible fiberscope, for ATI.

This is a clinical prospective randomized-controlled trial of non inferiority. The aim of this study is to compare the intubation success rate between two different devices (C-MAC Video Laryngoscope and VS-CMAC fiberoptic stylet) in patients with severe predicted difficult airways scheduled for elective surgery.

The primary endpoint is the comparison of success rate for the tracheal intubation, demonstrating the non inferiority of videostylet efficacy compared to the most consolidated technique based on videolaryngoscope.

Conditions

  • Difficult Airway Intubation

Interventions

DEVICE

VS-CMAC Rigid Fiberoptic Stylet

patients with severe predicted difficult airways scheduled for elective surgery randomized to this groups will receive awake endoscopic intubation using VS-CMAC Rigid Fiberoptic Stylet.

DEVICE

C-MAC Video laryngoscope awake intubation

patients with severe predicted difficult airways scheduled for elective surgery randomized to this groups will receive awake endoscopic intubation using C-MAC Video Laryngoscope intubation.

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Principal Investigators

  • Abele Donati, PhD, MD · Università Politecnica delle Marche

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532138 on ClinicalTrials.gov