Clinical trial NCT03546088: Awake Nasal Intubation in Laryngopharyngeal Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: awake intubation
nasal fiberscope
topical anesthesia
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The duration of the procedure
timeFrame: 10 minutes
Secondary outcomes:
measure: Momentary discomfort shown by coughing, grimacing, constricting vocal cords, limb movement or blunt cardiovascular response
timeFrame: 10 minutes
measure: Early and late complications
timeFrame: During procedure and 48 hours post-procedure
measure: Patient satisfaction about the procedure at 24 hours post-procedure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cluj Napoca
country: Romania
facility: Cluj County Emergency Hospital- ENT Clinic
state: Cluj
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy
name: Ioan Florin Marchis, Md
role: PRINCIPAL_INVESTIGATOR
References: