The Effects of Beclomethasone Upper the Endotracheal Cuff on the Occurrence of Sore Throat at Extubation (BEnTS)
Primary Purpose
Anesthesia, Endotracheal
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Beclomethasone
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia, Endotracheal focused on measuring intubation, intensive care, cardiac surgery, sore throat
Eligibility Criteria
Inclusion Criteria:
- intensive care postoperative admission
- tracheal intubation for a total lapse of time between 10 and 18 hours
Exclusion Criteria:
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Beclomethasone
Placebo
Arm Description
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.
Patients will receive 8 mL of saline without any drug.
Outcomes
Primary Outcome Measures
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
Minimal sore throat, less severe than with a cold
Moderate sore throat, similar to that noted with a cold
Severe sore throat, more severe than noted with a cold
Secondary Outcome Measures
Decrease of the incidence of hoarseness
Presence and degree of hoarseness by asking the patients to quantify it on a 0-3 scale (table 3). In addition patients will be asked to pronounce a prolonged "e" in order to assess the capacity to adduce vocal cords, an ENT evaluation will be requested.
Hoarseness Scoring System*
0 No evidence of hoarseness
Hoarseness that is noted by the patient only
Hoarseness that is easily noted
Full Information
NCT ID
NCT02687100
First Posted
February 10, 2016
Last Updated
February 23, 2021
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT02687100
Brief Title
The Effects of Beclomethasone Upper the Endotracheal Cuff on the Occurrence of Sore Throat at Extubation
Acronym
BEnTS
Official Title
Does Beclomethasone Instillation Above the Cuff of Endotracheal Tubes Decrease the Occurrence of Postoperative Sore Throat? A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to instillation site of the cortisone and the development of the related SARS-Cov2 infection, it was preferred to terminate the trial and develop it again without beclomethasone
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The study will be prospective, randomized, controlled. Patients will be premedicated with diazepam, 0.1 mg/Kg and scopolamine, 0.05 mg/Kg, i.m. one hour prior to their arrival in the operatory theatre. Anesthesia will be induced by fentanyl, 0.1 mg, and propofol, 1.5-2 mg/Kg. After obtaining muscle relaxation with cis-atracurium, 0.15 mg/Kg, a Taper Guard Evac Murphy Eye Oral Tracheal Tube (Mallinkrodt, Mirandola, Italy) with an internal diameter of 9 in men and 8 in women, will be positioned. These tubes have a line for suctioning above the cuff. The cuff pressure will be set to 20-30 cmH2O and checked every 6 hours with a proper inflating device. Patients will be connected to a mechanical ventilator and anesthesia will be maintained with sevoflurane 1-2.5% and remifentanil, 0.05-0.15 mcg/Kg/min. At the end of surgery, patients will be moved to the cardiac surgical intensive care, connected to a mechanical ventilator, and sedated with propofol and remifentanil until the conditions needed for weaning from the ventilator (control of bleeding, cardiovascular stability, thermal equilibrium) are achieved. Then, propofol infusion will be stopped and remifentanil dosage decreased to 0.02-0.05 mcg/Kg/min. After a successful t-tube trial of spontaneous breathing, tracheal tubes will be removed. Remifentanil infusion will be continued and dosage titrated on patient pain evaluated with a VAS scale; paracetamol 1 g will be given if need be.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Endotracheal
Keywords
intubation, intensive care, cardiac surgery, sore throat
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beclomethasone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive 8 mL of saline without any drug.
Intervention Type
Drug
Intervention Name(s)
Beclomethasone
Other Intervention Name(s)
Qvar, Beclovent, Vanceril, Vanceril DS
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
patients will receive 8 mL of saline without any drug
Primary Outcome Measure Information:
Title
Decrease of the incidence of sore-throat.
Description
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
Minimal sore throat, less severe than with a cold
Moderate sore throat, similar to that noted with a cold
Severe sore throat, more severe than noted with a cold
Time Frame
Fifteen minutes after removing the tracheal tube
Secondary Outcome Measure Information:
Title
Decrease of the incidence of hoarseness
Description
Presence and degree of hoarseness by asking the patients to quantify it on a 0-3 scale (table 3). In addition patients will be asked to pronounce a prolonged "e" in order to assess the capacity to adduce vocal cords, an ENT evaluation will be requested.
Hoarseness Scoring System*
0 No evidence of hoarseness
Hoarseness that is noted by the patient only
Hoarseness that is easily noted
Time Frame
Fifteen minutes after removing the tracheal tube
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
intensive care postoperative admission
tracheal intubation for a total lapse of time between 10 and 18 hours
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Cavaliere, MD
Organizational Affiliation
Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effects of Beclomethasone Upper the Endotracheal Cuff on the Occurrence of Sore Throat at Extubation
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