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Awake IntubationDexAwakeNCT05917847

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

An observational study of Awake Intubation, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Awake Intubation
What is being tested?
Awake intubation
How many people
24 participants
Where
1 siteItaly
Study dates
1 Jan 2019to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Primary care clinic

Who may be able to join

  • 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)

Who cannot join

  • Interdental distance <1 cm
  • Need for emergency airway stabilization.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Spedali Civili

    Brescia

Other trials in Italy

About this study

Official title: Awake VDL Intubation With Dexmedetomidine, a Case Series

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.

Read the 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.

Being tested
Awake intubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Awake intubationOther

    Awake videolaryngoscopic intubation with dexmedetomidine for sedation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of A-VDL success

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

    Measured: from the starting of sedation to the end of the intubation procedure

  2. The number of A-VDL intubation successes

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

    Measured: from the starting of sedation to the end of the intubation procedure

Secondary outcomes (5)
  1. Number of intubations allocated after A-VDL to VBS intubation.

    Airway stabilization

    Measured: from the starting of sedation to the end of the intubation procedure

  2. The kind of drugs used and dosage

    Type of drug and dosage

    Measured: from the starting of sedation to the end of the intubation procedure

  3. Level of sedation obtained

    Rass/ Ramsay

    Measured: from the starting of sedation to the end of the intubation procedure

  4. Presence absence of memory of pain or discomfort during the procedure

    Pain or discomfort remembered by the patient

    Measured: from the starting of sedation to the end of the intubation procedure

  5. Presence/absence of complications

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

    Measured: from the starting of sedation to the end of the intubation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start1 Jan 2019
  3. Primary completion1 Jul 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05917847
Sponsor's protocol ID
DA001
Acronym
DexAwake
Status last verified
Jun 2023
First submitted
15 Jun 2023
Last updated
26 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Awake Intubation, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of A-VDL success (time frame: from the starting of sedation to the end of the intubation procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.

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