Awake VDL Intubation With Dexmedetomidine, a Case Series (DexAwake)

Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)
Overall Status
Completed
CT.gov ID
NCT05917847
Collaborator
(none)
24
1
29.9
0.8

Study Details

Study Description

Brief Summary

Early after the videolaryngoscope'(VDL) introduction in clinical practice, the awake videolaryngoscopic (A-VDL) intubation took place with and instead of the awake video-bronchoscopic (A- VBS) intubation. The awake intubation is a safe profile technique that was underused since the only instrumentation available was the fiberoptic bronchoscope (FOB) or more recently the video-bronchoscope (VBS). With the VDL diffusion, the awake intubation option has eventually turned into a more utilized procedure, with the potential to become a daily procedure. This was also due to dexmedetomidine (DEX) introduction in The Operating Room pharmacopeia. Several steps must be standardized in order to homogeneously apply an awake intubation protocol. A department protocol is recommended (awake intubation guidelines) but a low threshold for enrollment can be used to shorten and standardize the execution times. This study aims to create a protocol and measure the outcomes.

Condition or Disease Intervention/Treatment Phase
  • Other: Awake intubation

Detailed Description

Early after the videolaryngoscope'(VDL) introduction in clinical practice, the awake videolaryngoscopic (A-VDL) intubation took place with and instead of the awake video-bronchoscopic (A- VBS) intubation. The awake intubation is a safe profile technique that was underused since the only instrumentation available was the fiberoptic bronchoscope (FOB) or more recently the video-bronchoscope (VBS). With the VDL diffusion, the awake intubation option has eventually turned into a more utilized procedure, with the potential to become a daily procedure. This was also due to dexmedetomidine (DEX) introduction in The Operating Room pharmacopeia.

The emergency use of rescue techniques after failed intubation throws the operator into the rare, but unwanted emergency "Front of Neck Access" (FONA) scenario, while a failed awake intubation brings (carry, get) the operator into the "patient not intubated but safely and spontaneously breathing" scenario, moving away from the events of hypoxic complications and death.

Several steps must be standardized in order to homogeneously apply an awake intubation protocol. First, the patients need to be clinically evaluated for difficult intubation predictors. Most of the articles about prediction only investigated the relationship between difficult intubation' predictors and direct laryngoscopy and they showed poor to moderate sensitivity and specificity (Toshiga Shiga, Vannucci) but, moving on VDL' world this relationship has changed as showed by Cortellazzi et al with an AUC for El Ganzouri Risk Index improving from 0.74 to 0.9 using DL and Glidescope respectively. In addition to these considerations, all the most recent Airway Management Guidelines has confirmed as unmissable the clinical evaluation of anthropometric and clinical DI predictors. (DAS) Along with measuring all the EGRI parameters, it is pivotal to examine any abnormality in the head, pharyngo-laryngeal, neck, spine, and abdominal anatomy. Previous neck irradiation, mass lesions, neck circumference, super-obesity, severe cervico-dorsal kyphosis, or past pharyngo-laryngeal surgery have to be considered and may not alter the EGRI score that is, incidentally, made -as the other predictors -for apparently normal patients (Shiga).

A department protocol is recommended (awake intubation guidelines) but a low threshold for enrollment can be used to shorten and standardize the execution times.

We retrospectively evaluated 24 patients (from January 2019 to June 2021). For descriptive purposes, there are five procedural "Times": T0, T1, T2, T3, T4 and T5. T 0 is the start of the dexmedetomidine charge dose and local oral-pharyngeal anesthetic. In T1, the GAG reflex check is performed. In T2 fentanyl or ketamine is delivered. In T3 the local anesthetic is nebulized on vocal cord and trachea, under videolaryngoscopic view. T4 is the tube passage through the vocal cords. T5 is the EtCo2 curve assessment. At the end outcomes were measured.

Study Design

Study Type:
Observational
Actual Enrollment :
24 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Awake VDL Intubation With Dexmedetomidine, a Case Series
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Jun 30, 2021

Outcome Measures

Primary Outcome Measures

  1. The number of A-VDL success [from the starting of sedation to the end of the intubation procedure]

    This was defined as the ability to identify good or poor glottic view without rupture of sedation or change in Rass/Ramsay sedation level.

  2. The number of A-VDL intubation successes [from the starting of sedation to the end of the intubation procedure]

    This was defined as the number of effective tube passages and airway stabilization.

Secondary Outcome Measures

  1. Number of intubations allocated after A-VDL to VBS intubation. [from the starting of sedation to the end of the intubation procedure]

    Airway stabilization

  2. The kind of drugs used and dosage [from the starting of sedation to the end of the intubation procedure]

    Type of drug and dosage

  3. Level of sedation obtained [from the starting of sedation to the end of the intubation procedure]

    Rass/ Ramsay

  4. Presence absence of memory of pain or discomfort during the procedure [from the starting of sedation to the end of the intubation procedure]

    Pain or discomfort remembered by the patient

  5. Presence/absence of complications [from the starting of sedation to the end of the intubation procedure]

    procedure abandonment for reasons other than poor glottic visualization, desaturation above 90%, bradycardia above 40

Other Outcome Measures

  1. Minutes from the beginning of sedation until airway stabilization [from the starting of sedation to the end of the intubation procedure]

    Time in minutes

  2. Cormack and Lehane score obtained [from the starting of sedation to the end of the intubation procedure]

    C&L

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Abnormality in the head, pharyngo-laryngeal, neck, spinal anatomy, super-obesity, El Ganzouri Risk Index > 6 or high risk for ab ingestis or hemorrhage (i.e.: tongue, pharynx-hypopharynx cancer lesions or arteriovenous malformations)
Exclusion Criteria:
  • Interdental distance <1 cm

  • Need for emergency airway stabilization.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Spedali Civili Brescia Italy

Sponsors and Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

  • Principal Investigator: Elena Cagnazzi, MD, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elena Cagnazzi, DM, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
ClinicalTrials.gov Identifier:
NCT05917847
Other Study ID Numbers:
  • DA001
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 26, 2023