Oro-tracheal Intubation: Flurbiprofen Subglottic Instillation to Prevent Laryngeal Inflammation

• Status: Not yet recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Most efficient system for airways controll during general anesthesia is oro-tracheal intubation, in order to allow mechanical ventilation and bronchial suction and to prevent gastric intake. However, in the period after exhumation, traumatism of tube placement causes in 21% to 72% of patients, sore throat (POST), generally associated hoarseness. The incidence of POST is influenced by numerous factors such as age, smoke history, duration of tube positioning maneuvers, diameter of the endotracheal tube, pressure present in the headset, duration of intubation. Although analgesics and systemically administered anti-inflammatories have been found to be effective, topical therapies based on the application of corticosteroids, NSAIDs and lidocaine are an interesting alternative because they are also effective, but devoid of the effects collateralises of systemic administration. The proposed methods for the prevention and treatment of POST in cardiac surgery patients, subjected to long-term interventions with consequent need for prolonged mechanical ventilation and therefore orotracheal intubation even in the post-operative period. The propose of trial is that the sub-glottal intake door can also be used for the peat administration of anti-inflammatory drugs in order to prevent pain caused by endotracheal intubation. This drug thus administered will directly reach the anatomical structures most involved in the genesis of post-intubation pain, that is, the vocal cords and the expected part of the trachea.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Treatments: Flurbiprofen

Criteria

Inclusion Criteria:

• Orotracheal intubation lasting 9-12 hours for elective interventions of myocardial revascularization or replacement/valve plastic in extracorporeal circulation and subsequent stay in intensive care.

• Ages of 50 and 75

• CLASS NYHA I or II

• Written consent to participation in the study and processing of their clinical data for the purpose of the study

Exclusion Criteria:

• Previous upper air screw surgery

• Positive history for recent acute or chronic diseases of upper airways

• Tabagism

• Positive history for difficult intubation

• Orotracheal intubation with more than two attempts or with the help of devices

• Naso-tracheal intubation

• Positive history for gastro-esophageal reflux

• Patients who have or have been affected by peptic ulcer

• Patients with known hypersensitivity (bronchial asthma, urticaria, allergic phenomena) to flurbiprofen or any of the excipients, and to aspirin and other drugs belonging to the category of nonsteroidal anti-inflammatory drugs (NSAIDs)

• Pregnant and lactating women

• Patients participating in other experimental trials

• Patients who have not given written consent

• Any other clinical condition that the investigator says would make the patient unfit for study.