Airway Complication of Anesthesia Clinical Trial
Official title:
Awake Fiber Optic Intubation (AFOI) in Patients With Stenosis of the Upper Airway: Utility of the Laryngeal Nervous Block
NCT number | NCT03586323 |
Other study ID # | AFOISUA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 15, 2018 |
Est. completion date | August 1, 2018 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 1, 2018 |
Est. primary completion date | July 24, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - aged >18 years - undergoing elective AFOI for upper airway obstruction Exclusion Criteria: - patients with respiratory tirage and cornage - Arnè multifactorial scale < 11 |
Country | Name | City | State |
---|---|---|---|
Italy | Sapienza University of Rome | Roma |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | incidence of hypoxemia | number of desaturation events | up to 10 minutes | |
Secondary | time required to intubate | minutes to intubation | up to 10 minutes | |
Secondary | intraprocedural hemodynamic stability | reducing blood pressure > 30% | up to 10 minutes |
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