Awake Nasal Intubation in Laryngopharyngeal Tumors

Airway Management Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546088
• Other study ID #: marchisioan
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: December 25, 2018

Study information

• Verified date: July 2020
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 25, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management

Intervention

Device:
• fiberoptic naso-tracheal intubation
The trachea will be intubated under direct fiberoptic view after a fiberoptic upper airway examination. The flexible nasolaryngoscope will be armed with an intubating tube and passed inside tracheal lumen trough one of the nostrils.

Drug:
• Topical anaesthesia
Topical anaesthesia with lidocaine will be provided through nebulisation and instillation. The intubating tube will be lubricated with a gel containing lidocaine.
• Light sedation
The patient will be sedated with a combination of midazolam, fentanyl administered intravenously in small boluses until the desired level of sedation is achieved as expressed of The Observer's Assessment of Alertness/Sedation Scale (OAA/S) of 4 or 5.

Locations

Country	Name	City	State
Romania	Cluj County Emergency Hospital- ENT Clinic	Cluj Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of the procedure	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.	10 minutes
Secondary	Momentary discomfort shown by coughing, grimacing, constricting vocal cords, limb movement or blunt cardiovascular response	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.	10 minutes
Secondary	Early and late complications	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)	During procedure and 48 hours post-procedure
Secondary	Patient satisfaction about the procedure at 24 hours post-procedure	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.	24 hours