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

NCT05917847 | Completed

• 1 other identifier: DA001
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Awake Intubation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Other Outcomes (2)

• 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

Interventions

Awake intubation OTHER

Awake videolaryngoscopic intubation with dexmedetomidine for sedation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Spedali Civili

Brescia, Italy

Location

Study Officials

• Elena Cagnazzi, MD

  Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DM

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: January 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: June 30, 2021
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

IT (1)