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
Verified date | July 2020 |
Source | Iuliu Hatieganu University of Medicine and Pharmacy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Romania | Cluj County Emergency Hospital- ENT Clinic | Cluj Napoca | Cluj |
Lead Sponsor | Collaborator |
---|---|
Iuliu Hatieganu University of Medicine and Pharmacy |
Romania,
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 |
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