Awake Fiber Optic Intubation (AFOI) and Laryngeal Nervous Block
1 other identifier
interventional
40
1 country
1
Brief Summary
Oncologic laryngeal surgery is a challenge for anesthesiologists and awake fiberoptic intubation (AFOI) is mandatory to manage difficult airways and prevent the Can't Intubate Can't Oxigenate (CICO). Laryngospasm and oversedation are dangerous complication often life-threatening in this kind of patient. Superior laryngeal nerve block (SLNB) could be an alternative technique useful to reduce risks and to improve patient comfort. Aim of this study is to assess the procedural comfort of the SLNB during AFOI, in a population of patients suffering from severe airways obstruction undergoing pharyngeal-laryngeal surgery. 40 patients will be randomized in two groups(20 for each group) and will be treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue and intercricoid block. In group A will be associated the SLNB; placebo will be administered in group B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2018
CompletedFirst Submitted
Initial submission to the registry
June 29, 2018
CompletedFirst Posted
Study publicly available on registry
July 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJuly 17, 2018
July 1, 2018
3 months
June 29, 2018
July 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
discomfort
to evaluate if SLNB is able to reduce the degree of discomfort of the AFOI procedure measured with the relative risk of Fiber Optic Intubation Comfort Score \> 1
up to 10 minutes
Secondary Outcomes (3)
incidence of hypoxemia
up to 10 minutes
time required to intubate
up to 10 minutes
intraprocedural hemodynamic stability
up to 10 minutes
Study Arms (2)
L-SLNB
EXPERIMENTALperformed a superior laryngeal nerve block with lidocaine
S-SLNB
PLACEBO COMPARATORperformed a superior laryngeal nerve block with saline
Interventions
SLNB was performed with 4 ml of 1.5% lidocaine below the thyroid membrane
Eligibility Criteria
You may qualify if:
- aged \>18 years
- undergoing elective AFOI for upper airway obstruction
You may not qualify if:
- patients with respiratory tirage and cornage
- Arnè multifactorial scale \< 11
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sapienza University of Rome
Roma, 00100, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 29, 2018
First Posted
July 13, 2018
Study Start
April 15, 2018
Primary Completion
July 24, 2018
Study Completion
August 1, 2018
Last Updated
July 17, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share