Oro-tracheal Intubation: Flurbiprofen Subglottic Instillation to Prevent Laryngeal Inflammation
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 12, 2021
Trial Information
Current as of July 21, 2025
Unknown status
Keywords
ClinConnect Summary
Orotracheal intubation is the most efficient system for controlling the airways during general anesthesia, in order to keep them harmful, to prevent gastric intake and to allow mechanical ventilation and bronchial suction. However, a percentage ranging from 21% to 72% of patients undergoing orotracheal intubation have, in the period after exhumation, sore throat (POST) generally associated hoarseness. This complication stems from traumatism caused by tube placement and pressure exerted on the vocal cords and trachea wall during in situ parking. The incidence of POST is influenced by numerou...
Gender
ALL
Eligibility 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.
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Maria Calabrese, MD
Principal Investigator
Fondazione Policlinico A. Gemelli IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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