Awake Fiberoptic Intubation Clinical Trial
Official title:
A Comparative Study Between Atomization and Nebulization for Airway Topicalization During Awake Nasotracheal Fiberoptic Intubation
NCT number | NCT05320731 |
Other study ID # | 9351 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 20, 2022 |
Est. completion date | July 20, 2024 |
Intubation of difficult airway is a challenge for anesthetist. There many causes of difficult airway, and previous studies concluded that awake fiber-optic intubation (AFOI) is the gold standard for the management of these patients. Several studies showed that airway nerve blocks provide rapid and deep airway anesthesia, however, due to their several disadvantages, topicalization of the airway represents a promising alternative to them. Some studies revealed that nebulization and atomization of the airway provide adequate anesthesia for AFOI. In the present study, we try to find out which is more effective for topicalization of the airway during nasotracheal AFOI; nebulization or atomization. We used a simple atomization device as a modification of the McKenzie technique.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | July 20, 2024 |
Est. primary completion date | June 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Consent obtained from all patients included in this study. 2. Age 18 - 60 years, of both sexes. 3. ASA class I, II and III. 4. Anticipated difficult airway; SARI score = 4, airway pathology, craniofacial abnormalities, or cervical spine instability. 5. Scheduled for elective non-cardiac surgery requiring general anesthesia and endotracheal intubation. Exclusion Criteria: 1. Patient refusal, uncooperative and mentally retarded patients. 2. Full stomach patients. 3. Patients with nasal fractures or trauma, fracture base of the skull, bleeding disorder, epistaxis or active oral bleeding. 4. Active cough or respiratory tract infection and bronchial asthma. 5. Allergy to lidocaine. 6. Raised intracranial pressure or intraocular pressure. 7. Cerebral aneurysm, history of recent acute myocardial infarction or cerebrovascular accident. |
Country | Name | City | State |
---|---|---|---|
Egypt | Zagazig university hospitals | Zagazig | Sharkia |
Lead Sponsor | Collaborator |
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Zagazig University |
Egypt,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bronchoscopy-guided intubation time | Time from passing the flexible fiberoptic bronchoscope tip through the nostril to the first reading obtained by the capnograph after endotracheal intubation | Intraoperative (during intubation) | |
Secondary | Intubating Condition Score: | Optimal (Best); No hold-up or collision of tracheal tube with vocal cords. Suboptimal; Hold-up relieved by one rotation of the tube. Difficult; Hold-up requiring more than one rotation of the tube. Failure (Worst); Failed attempt at awake fiberoptic intubation. | Intraoperative (during intubation) | |
Secondary | Vocal Cord Position Score: | 1; Relaxed (Best), 2; Partially Relaxed and 3; Adducted (Worst) | Intraoperative (during intubation) | |
Secondary | Intraoperative Patient Comfort Score: | A. Cough & Gag Severity:
1; None (Best), 2; Minimal coughing or gagging (< 3 times) like "clearing throat", 3; Mild coughing or gagging lasting < 1 min., and 4; Persistent coughing or gagging (Worst). B. Comfort during Intubation: 1; No reaction (Best), 2; Slight grimacing, 3; Severe grimacing, 4; Verbal objection, and 5; Defensive movements of headBest), hands, or feet (Worst). C. Post-intubation Assessment: 1; Cooperative (Best), 2; Restless/minimal resistance, and 3; Severe resistance/ requirement for immediate general anesthesia (Worst). |
Intraoperative (during and immediately post-intubation) | |
Secondary | Postoperative Patient Satisfaction Score: | 1; Excellent (Best), 2; Good, 3; Fair and 4: Poor (Worst). | Postoperative 24 hours |
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