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

Awake VDL Intubation With Dexmedetomidine, a Case Series

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05917847
Acronym
DexAwake
Enrollment
24
Registered
2023-06-26
Start date
2019-01-01
Completion date
2021-06-30
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Awake Intubation

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.

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.

Interventions

Awake videolaryngoscopic intubation with dexmedetomidine for sedation

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
The number of A-VDL successfrom the starting of sedation to the end of the intubation procedureThis was defined as the ability to identify good or poor glottic view without rupture of sedation or change in Rass/Ramsay sedation level.
The number of A-VDL intubation successesfrom the starting of sedation to the end of the intubation procedureThis was defined as the number of effective tube passages and airway stabilization.

Secondary

MeasureTime frameDescription
Presence/absence of complicationsfrom the starting of sedation to the end of the intubation procedureprocedure abandonment for reasons other than poor glottic visualization, desaturation above 90%, bradycardia above 40
Level of sedation obtainedfrom the starting of sedation to the end of the intubation procedureRass/ Ramsay
Presence absence of memory of pain or discomfort during the procedurefrom the starting of sedation to the end of the intubation procedurePain or discomfort remembered by the patient
Number of intubations allocated after A-VDL to VBS intubation.from the starting of sedation to the end of the intubation procedureAirway stabilization
The kind of drugs used and dosagefrom the starting of sedation to the end of the intubation procedureType of drug and dosage

Other

MeasureTime frameDescription
Cormack and Lehane score obtainedfrom the starting of sedation to the end of the intubation procedureC&L
Minutes from the beginning of sedation until airway stabilizationfrom the starting of sedation to the end of the intubation procedureTime in minutes

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026