Awake Nasal Intubation With a Flexible Nasolaryngoscope in Patients With Laryngeal, Oro and Hypo-pharynx Tumours With Midazolam-fentanyl-droperidol Sedation Protocol- Technique and Patient Satisfaction
Overview
- Phase
- Not Applicable
- Intervention
- fiberoptic naso-tracheal intubation
- Conditions
- Airway Management
- Sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- The duration of the procedure
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study evaluates the efficiency of awake naso-tracheal intubation and patient satisfaction when using a small diameter flexible nasolaryngoscope together with topical anaesthesia and light sedation with a combination of benzodiazepine and fentanyl. The selected patients will have difficult airway access because of obstructing oro- and hypo-pharynx tumours.
Detailed Description
Awake naso-tracheal fiberoptic intubation is an established method of securing a difficult airway. The patient's comfort and optimum intubation conditions are paramount for success. The study proposes to analyse a series of patients with obstructive pharyngo-laryngeal pathology, following the degree of satisfaction, reliability of the procedure and any incidents or complications. Awake intubation could be the safest way to control difficult airway as the patient maintains spontaneous respiration and intact reflexes. Main concerns for the success of this procedure should be a good technique, a calm and cooperative patient and good preparation with careful topical anaesthesia and appropriate sedation. The tool used in this study will be a flexible nasolaryngoscope of 2.9 mm diameter and 300 mm working length which might offer an advantage over lengthier fiberscopes in matter of manoeuvrability and patient comfort. Prior intubation the patients will have an upper airway fiberscopic exam from nostrils to tracheae with the same tool.
Investigators
Marchis Ioan Florin
Principal Investigator- Head of the Anaesthesia Dept. of ENT Clinic- Cluj Napoca
Iuliu Hatieganu University of Medicine and Pharmacy
Eligibility Criteria
Inclusion Criteria
- •patients with tumours of larynx, oro and hypo-pharynx that obstruct airway access.
Exclusion Criteria
- •Patients who refuse the procedure, with bleeding disorders, acute respiratory failure manifested by stridor or the impossibility of nasal passage are excluded from the study.
Arms & Interventions
awake naso-tracheal intubation
The patients with obstructive oro and hypo-pharynx tumours will have their airway secured through awake fiberoptic naso-tracheal intubation with light sedation and topical anaesthesia with lidocaine. The sedation will be provided in small boluses until the desired level will be achieved not exceeding 0.05 mg/kg of midazolam and 3 mcg/kg fentanyl. The dose of lidocaine will be to a maximum of 7 mg/kg. The reinforced intubating tube will be lubricated with lidocaine gel.
Intervention: fiberoptic naso-tracheal intubation
awake naso-tracheal intubation
The patients with obstructive oro and hypo-pharynx tumours will have their airway secured through awake fiberoptic naso-tracheal intubation with light sedation and topical anaesthesia with lidocaine. The sedation will be provided in small boluses until the desired level will be achieved not exceeding 0.05 mg/kg of midazolam and 3 mcg/kg fentanyl. The dose of lidocaine will be to a maximum of 7 mg/kg. The reinforced intubating tube will be lubricated with lidocaine gel.
Intervention: Topical anaesthesia
awake naso-tracheal intubation
The patients with obstructive oro and hypo-pharynx tumours will have their airway secured through awake fiberoptic naso-tracheal intubation with light sedation and topical anaesthesia with lidocaine. The sedation will be provided in small boluses until the desired level will be achieved not exceeding 0.05 mg/kg of midazolam and 3 mcg/kg fentanyl. The dose of lidocaine will be to a maximum of 7 mg/kg. The reinforced intubating tube will be lubricated with lidocaine gel.
Intervention: Light sedation
Outcomes
Primary Outcomes
The duration of the procedure
Time Frame: 10 minutes
The duration of the successful naso-tracheal intubation, starting from the passage of the intubating tube through one of the nostrils until the endotracheal intubation confirmation by free bag movement and capnography.
Secondary Outcomes
- Momentary discomfort shown by coughing, grimacing, constricting vocal cords, limb movement or blunt cardiovascular response(10 minutes)
- Early and late complications(During procedure and 48 hours post-procedure)
- Patient satisfaction about the procedure at 24 hours post-procedure(24 hours)