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Completed

NCT Number: NCT05917847

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

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spedali Civili

Brescia, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

awake intubation

Other

Awake videolaryngoscopic intubation with dexmedetomidine for sedation

Primary outcomes

  1. The number of A-VDL success

    Time frame: 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

    Time frame: 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 outcomes

  1. Number of intubations allocated after A-VDL to VBS intubation.

    Time frame: from the starting of sedation to the end of the intubation procedure

    Airway stabilization

  2. The kind of drugs used and dosage

    Time frame: from the starting of sedation to the end of the intubation procedure

    Type of drug and dosage

  3. Level of sedation obtained

    Time frame: 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

    Time frame: from the starting of sedation to the end of the intubation procedure

    Pain or discomfort remembered by the patient

  5. Presence/absence of complications

    Time frame: 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 outcomes

  1. Minutes from the beginning of sedation until airway stabilization

    Time frame: from the starting of sedation to the end of the intubation procedure

    Time in minutes

  2. Cormack and Lehane score obtained

    Time frame: from the starting of sedation to the end of the intubation procedure

    C&L

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

Awake VDL Intubation With Dexmedetomidine, a Case Series

Acronym: DexAwake

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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