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

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ClinicalTrials.gov Identifier: NCT02687100
Recruitment Status : Unknown
Verified August 2016 by Temistocle Taccheri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Recruitment status was:  Not yet recruiting
First Posted : February 22, 2016
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
Temistocle Taccheri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Condition or disease Intervention/treatment Phase
Anesthesia, Endotracheal Drug: Beclomethasone Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Beclomethasone Instillation Above the Cuff of Endotracheal Tubes Decrease the Occurrence of Postoperative Sore Throat? A Randomized Controlled Trial
Study Start Date : October 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Experimental: Beclomethasone
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
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
Other Name: Qvar, Beclovent, Vanceril, Vanceril DS

Placebo Comparator: Placebo
Patients will receive 8 mL of saline without any drug.
Drug: Placebo
patients will receive 8 mL of saline without any drug




Primary Outcome Measures :
  1. Decrease of the incidence of sore-throat. [ Time Frame: Fifteen minutes after removing the tracheal tube ]

    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


Secondary Outcome Measures :
  1. Decrease of the incidence of hoarseness [ Time Frame: Fifteen minutes after removing the tracheal tube ]

    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

    1. Hoarseness that is noted by the patient only
    2. Hoarseness that is easily noted



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Ages Eligible for Study:   18 Months to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687100


Contacts
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Contact: Temistocle Taccheri, MD 3470526726 ext +39 taccheri.temistocle@gmail.com
Contact: Simone Carelli, MD 3407465537 ext +39 simonecarelli.sc@gmail.com

Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
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Principal Investigator: Franco Cavaliere, MD Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome

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Responsible Party: Temistocle Taccheri, MD, resident of Department of Anesthesia and Intensive Care , Policlinico A. Gemelli , Catholic University of the Sacred Heart in Rome, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT02687100    
Other Study ID Numbers: DMC
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Temistocle Taccheri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
intubation
intensive care
cardiac surgery
sore throat
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents