The Effects of Beclomethasone Upper the Endotracheal Cuff on the Occurrence of Sore Throat at Extubation

NCT02687100 | Withdrawn Phase 4 DMC

• 1 other identifier: DMC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to test the effectiveness of a solutions of beclomethasone repeatedly instilled through the supraglottic line of the endotracheal tube on post-extubation airway disturbances related to tracheal intubation. The primary endpoint will be the decrease of the incidence of sore-throat 15 minutes and 12 hours after extubation. Secondary endpoints will regard the effects on hoarseness and cough.

Conditions

Anesthesia, Endotracheal

Keywords

intubation; intensive care; cardiac surgery; sore throat

Outcome Measures

Primary Outcomes (1)

• Decrease of the incidence of sore-throat.

  Presence and intensity of sore throat by asking the patients to quantify it on a 0-3 scale Sore Throat Scoring System\* 0 No sore throat 1. Minimal sore throat, less severe than with a cold 2. Moderate sore throat, similar to that noted with a cold 3. Severe sore throat, more severe than noted with a cold

  Fifteen minutes after removing the tracheal tube

Secondary Outcomes (1)

• Decrease of the incidence of hoarseness

  Fifteen minutes after removing the tracheal tube

Study Arms (2)

Beclomethasone

EXPERIMENTAL

Patients will receive beclomethasone, 0.8 mg of saline to a volume of 8 mL, three times through the line for suctioning above the cuff: a) after positioning the tube; b) at the arrival in the cardiac intensive care unit; c) just prior to start respiratory weaning. The solution will be aspirated 15 minutes after the instillation.

Drug: Beclomethasone

Placebo

PLACEBO COMPARATOR

Patients will receive 8 mL of saline without any drug.

Drug: Placebo

Interventions

Beclomethasone DRUG

beclometasone, 0.8 mg of saline to a volume of 8 mL, three times through the line for suctioning above the cuff: a) after positioning the tube; b) at the arrival in the cardiac intensive care unit; c) just prior to start respiratory weaning

Also known as: Qvar, Beclovent, Vanceril, Vanceril DS

Beclomethasone

Placebo DRUG

patients will receive 8 mL of saline without any drug

Placebo

Eligibility Criteria

• Age: 18 Months - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• intensive care postoperative admission
• tracheal intubation for a total lapse of time between 10 and 18 hours

You may not qualify if:

• age \< 18,
• hypersensitivity to FANS and/or corticosteroids,
• a medical history positive for diseases affecting upper airways or trachea or causing cough, hoarseness, or voice disorders;
• intubation after more than two attempts or with aids (i.e. stylets, Airtraq, Glidescope, Fibroscopy).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Pharyngitis

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Franco Cavaliere, MD

  Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, resident of Department of Anesthesia and Intensive Care , Policlinico A. Gemelli , Catholic University of the Sacred Heart in Rome

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 22, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share