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.
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.
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.
- Conditions
- Awake Intubation
- 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.
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
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)
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
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
Level of sedation obtained
Rass/ Ramsay
Measured: from the starting of sedation to the end of the intubation procedure
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
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.
- First posted26 Jun 2023
- Study start1 Jan 2019
- Primary completion1 Jul 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awake IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Cagnazzi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Elena Cagnazzi, MD, Principal investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake VDL Intubation With Dexmedetomidine, a Case Series
- ClinicalTrials.gov ID
- NCT05917847
- Acronym / sponsor ID
- DexAwake / DA001
- Conditions
- Awake Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Interdental distance <1 cm
- Need for emergency airway stabilization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Awake intubationAwake videolaryngoscopic intubation with dexmedetomidine for sedation | Other | – |
Primary outcome
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.
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.
5 secondary outcomes
Number of intubations allocated after A-VDL to VBS intubation.
Time frame: from the starting of sedation to the end of the intubation procedure
The kind of drugs used and dosage
Time frame: from the starting of sedation to the end of the intubation procedure
Level of sedation obtained
Time frame: from the starting of sedation to the end of the intubation procedure
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
Presence/absence of complications
Time frame: from the starting of sedation to the end of the intubation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Cagnazzi, MD principal investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
1 site in 1 country: see every site and its status.
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.