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

NCT04532138 | Unknown

• 1 other identifier: D-BLADE - VS
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

difficult airway; difficult intubation; awake endoscopic intubation; rigid fiberoptic stylet

Outcome Measures

Primary Outcomes (1)

• the success rate of the rigid fiberoptic stylet to perform tracheal intubation in patients with anticipated difficult airways

  The primary endopoint is the comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of videostylet efficacy compare to the most consolidated technique based on videolaryngoscope. success rate of the procedure defined as correct positioning of the tracheal tube in the trachea confirmed both endoscopically and through the capnographic curve EtCO2

  up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 minutes)

Secondary Outcomes (5)

• Numbers of intubation attempts

  up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 minutes)

• average time of intubation procedure expressed in seconds

  up to 15 minutes

• Development of any complications

  up to 12 hours measured from the insertion of the device

• The degree of patient's tolerability of the procedure (with a special Analogue Numerical Scale)

  up to 12 hours from the beginning of the procedure (from starting of awake intubation to complete recovering from general anaesthesia)

• The degree of subjective difficulty experienced by the operator

  up to 15 minutes (from device insertion into the patient's mouth until the ETT will be positioned into the trachea)

Study Arms (2)

C-MAC Video laryngoscope awake intubation

ACTIVE COMPARATOR

In this group, patients with severe predicted difficult airways scheduled for elective surgery receive awake endoscopic intubation using Videolaryngoscope (C-MAC) with Hyperangulated blade (D-blade) Spontaneous breathing will be preserved in both groups of patients enrolled and the same protocol of sedation plus upper airways topical anesthesia will be applied.

Device: C-MAC Video laryngoscope awake intubation

VS-CMAC Rigid Fiberoptic Stylet awake intubation

EXPERIMENTAL

In this group, patients with severe predicted difficult airways scheduled for elective surgery receive awake endoscopic intubation using VS-CMAC Rigid Fiberoptic Stylet. Spontaneous breathing will be preserved in both groups of patients enrolled and the same protocol of sedation plus upper airways topical anesthesia will be applied.

Device: VS-CMAC Rigid Fiberoptic Stylet

Interventions

VS-CMAC Rigid Fiberoptic Stylet DEVICE

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.

VS-CMAC Rigid Fiberoptic Stylet awake intubation

C-MAC Video laryngoscope awake intubation DEVICE

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.

Also known as: videolaryngoscope with hyperangulated blade

C-MAC Video laryngoscope awake intubation

Eligibility Criteria

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

You may qualify if:

• Schedule for elective surgery
• Detection of one or more of the following anthropometric criteria predictive of difficult intubation at the preoperative visit:
• Limitation of Cervical spine movements (traumatic or surgical arthrodesis)
• Mallampati score = 4
• Thyromental distance \< 6 cm
• Interincisor distance \< 3 cm
• Suspected difficult ventilation via face mask
• Previous history of difficult or failed intubation

You may not qualify if:

• age \<18 years
• refusal of the patient
• urgent-emergency surgery
• patient's respiratory failure

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

AOU Ospedali Riuniti Ancona - Università Politecnica delle Marche

Ancona, 60126, Italy

RECRUITING

Study Officials

• Abele Donati, PhD, MD

  Università Politecnica delle Marche

  STUDY DIRECTOR

Central Study Contacts

Abele Donati, PhD, MD

CONTACT

00390715963858; a.donati@univpm.it

Stefano Falcetta, MD

CONTACT

00390715964603; falmed@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Clinic of Anaesthesia and Intensive Care, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: August 31, 2020
• Study Start: May 27, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)