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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Withdrawn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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia, Endotracheal focused on measuring intubation, intensive care, cardiac surgery, sore throat

Eligibility Criteria

18 Months - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 10, 2016
    Last Updated
    February 23, 2021
    Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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    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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