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

NCT04708964 | Unknown Phase 2

• 1 other identifier: Sore Throat Pilot
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

D010612

Keywords

Sore Throat; Endotracheal Intubation; Flurbiprofen

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of a flurbiprofen solution, administered through the subglottic intake port of endotracheal tubes, on the incidence and intensity of the Sore Throat Post Operative

  Decrease of Sore Throat Pain Intensity Scale (STPIS) and Throat Pain Scale (TPS)

  ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ●TDim: Time of discharge

Secondary Outcomes (2)

• Evaluate the intensity of hoarseness Evaluate the intensity of hoarseness

  ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ● TDim: Time of discharge

• Patients Satisfaction

  ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ● TDim: Time of discharge

Study Arms (2)

Flurbiprofen

ACTIVE COMPARATOR

5 ml of flurbiprofen solution 0.25% will be administered, through the subglottic intake door of the endotracheal tube. The solution will be left in place for 1 minute

Drug: Flurbiprofen

Placebo

PLACEBO COMPARATOR

5 ml of saline solution 0.9% will be administered, through the subglottic intake door of the endotracheal tube. The solution will be left in place for 1 minute

Drug: saline solution

Interventions

Flurbiprofen DRUG

Flurbiprofen solution will be administered, through the subglottic intake door of the endotracheal tube.

Flurbiprofen

saline solution DRUG

Saline solution will be administered, through the subglottic intake door of the endotracheal tube.

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Pharyngitis

Interventions

Flurbiprofen; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Maria Calabrese, MD

  Fondazione Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Calabrese, MD

CONTACT

+393925532600; maria.calabrese@policlinicogemelli.it

Temistocle Taccheri, MD

CONTACT

+393470526726; taccheri.temistocle@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: January 31, 2022
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share