SUBGLOTTIC INSTILLATION OF FLURBIPROFENE TO PREVENT LARYNGEAL INFLAMMATION FOLLOWING ENDOTRACHEAL INTUBATION: PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED PILOT STUDY

Phase 1

• Conditions: Sore throat generally associated with cough and hoarseness after orotracheal intubation.; MedDRA version: 23.1Level: LLTClassification code 10041367Term: Sore throatSystem Organ Class: 100000004855; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-000886-17-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

¿Patients undergoing 9-12 hours orotracheal intubation for aortocoronary bypass, valve replacement
¿Plastic surgery in extracorporeal circulation
¿Patient aged between 50 and 75
¿Patients in NYHA class I and II
¿Patients who have given their written consent to the study and treatment of their clinical data for the purpose of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Exclusion criteria
¿Previous upper airway surgery
¿A positive history of recent acute pathologies or chronic pathologies of the upper airways
¿Nicotine addiction
¿Positive history of difficult intubation including objective examination suggestive of difficult
orotracheal intubation (Mallampati = 3)
¿Orotracheal intubation with more than two attempts or with the aid of devices (spindles, Airtrag, Fibroscopy)
¿Nasotracheal intubation
¿Positive history of gastroesophageal reflux
¿Patients participating in other experimental trials
¿Patients who have not given their written consent to participate in the study and have specifically refused the use of their clinical data for the purpose of the study and have not given their consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified