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NCT Number: NCT03546088

Awake Nasal Intubation in Laryngopharyngeal Tumors

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.

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Key information

Conditions

Airway Management

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cluj County Emergency Hospital- ENT Clinic

Cluj-Napoca, Cluj, 400006, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fiberoptic naso-tracheal intubation

Device

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.

Topical anaesthesia

Drug

Topical anaesthesia with lidocaine will be provided through nebulisation and instillation. The intubating tube will be lubricated with a gel containing lidocaine.

Light sedation

Drug

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.

Primary outcomes

  1. 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

  1. Momentary discomfort shown by coughing, grimacing, constricting vocal cords, limb movement or blunt cardiovascular response

    Time frame: 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.

  2. Early and late complications

    Time frame: 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)

  3. Patient satisfaction about the procedure at 24 hours post-procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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