Awake Nasal Intubation in Laryngopharyngeal Tumors
- Conditions
- Airway Management
- Interventions
- Device: fiberoptic naso-tracheal intubationDrug: Topical anaesthesiaDrug: Light sedation
- Registration Number
- NCT03546088
- Lead Sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- patients with tumours of larynx, oro and hypo-pharynx that obstruct airway access.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description awake naso-tracheal intubation Light sedation 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. awake naso-tracheal intubation fiberoptic 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. awake naso-tracheal intubation Topical anaesthesia 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.
- Primary Outcome Measures
Name Time Method The duration of the procedure 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 Outcome Measures
Name Time Method Momentary discomfort shown by coughing, grimacing, constricting vocal cords, limb movement or blunt cardiovascular response 10 minutes Expressed by grimacing, coughing , laryngospasm or constricting vocal cords, limb movement, a cardiovascular response of more than 20% variation in mean arterial pressure or cardiac frequency, rhythm disturbances.
Early and late complications During procedure and 48 hours post-procedure monitoring incidents which could appear during or after the procedure (failure of achieving tracheal intubation, respiratory or cardio-vascular life threatening incidents, local injuries, bleeding, accidental tube displacement or blocking)
Patient satisfaction about the procedure at 24 hours post-procedure 24 hours The subjects will complete a satisfaction questionnaire, in the form of a visual analogue scale. The scale will have the form of a 10 cm line marked with five grades of their discomfort during the procedure: none, mild, moderate, very bad and unbearable. Above this written words there is a 1 to 10 scale on which the patient will note there satisfaction score- 1 is the corespondent of no discomfort and 10 is for unbearable. The patient will fill in the scale the day after surgery. An average of the score of all patients will be computed.
Trial Locations
- Locations (1)
Cluj County Emergency Hospital- ENT Clinic
🇷🇴Cluj Napoca, Cluj, Romania