NCT05917847|Completed
Awake VDL Intubation With Dexmedetomidine, a Case Series (DexAwake)
DexAwake
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DexAwake
Sponsor study identifier
observational
24
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
July 1, 2020
Actual (reported)Study Completion
June 30, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)July 1, 2020
Actual (reported)June 30, 2021
Actual (reported)June 15, 2023
Actual (reported)June 26, 2023
Actual (reported)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.
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.
from the starting of sedation to the end of the intubation procedure
Number of intubations allocated after A-VDL to VBS intubation.
from the starting of sedation to the end of the intubation procedure
The kind of drugs used and dosage
from the starting of sedation to the end of the intubation procedure
Level of sedation obtained
from the starting of sedation to the end of the intubation procedure
Presence absence of memory of pain or discomfort during the procedure
from the starting of sedation to the end of the intubation procedure
Presence/absence of complications
from the starting of sedation to the end of the intubation procedure
Minutes from the beginning of sedation until airway stabilization
from the starting of sedation to the end of the intubation procedure
Cormack and Lehane score obtained
from the starting of sedation to the end of the intubation procedure
Awake videolaryngoscopic intubation with dexmedetomidine for sedation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary care clinic
Spedali Civili
Brescia, Italy
Elena Cagnazzi, MD
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
24 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2023
First Posted
June 26, 2023
Study Start
January 1, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 1, 2020
Actual (reported)Study Completion
June 30, 2021
Actual (reported)Last Updated
June 26, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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