Anesthesia, EndotrachealPhase 4BEnTSNCT02687100
The Effects of Beclomethasone Upper the Endotracheal Cuff on the Occurrence of Sore Throat at Extubation
A Phase 4 study testing Beclomethasone in people with Anesthesia, Endotracheal, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 90 years
- Conditions the study is for
- Anesthesia, Endotracheal
- What is being tested?
- Beclomethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- intensive care postoperative admission
- tracheal intubation for a total lapse of time between 10 and 18 hours
Who cannot join
- 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).
About this study
Official title: Does Beclomethasone Instillation Above the Cuff of Endotracheal Tubes Decrease the Occurrence of Postoperative Sore Throat? A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Anesthesia, Endotracheal
- Being tested
- Beclomethasone, Placebo
- Keywords
- intubation, intensive care, cardiac surgery, sore throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeclomethasoneDrug
Also called Qvar, Beclovent, Vanceril, Vanceril DS
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
PlaceboDrug
patients will receive 8 mL of saline without any drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Beclomethasone |
| Placebo | Placebo comparator | Patients will receive 8 mL of saline without any drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Fifteen minutes after removing the tracheal tube
Secondary outcomes (1)
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
Measured: Fifteen minutes after removing the tracheal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, EndotrachealStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Temistocle Taccheri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Franco Cavaliere, MD, Principal investigator, Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687100
- Sponsor's protocol ID
- DMC
- Acronym
- BEnTS
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2016
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Beclomethasone Instillation Above the Cuff of Endotracheal Tubes Decrease the Occurrence of Postoperative Sore Throat? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02687100
- Acronym / sponsor ID
- BEnTS / DMC
- Conditions
- Anesthesia, Endotracheal
- Keywords
- intubation, intensive care, cardiac surgery, sore throat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beclomethasone | Experimental | Drug: BeclomethasonePatients 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. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive 8 mL of saline without any drug. |
Who may qualify
- Ages
- 18 months to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- intensive care postoperative admission
- tracheal intubation for a total lapse of time between 10 and 18 hours
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeclomethasoneAlso: Qvar, Beclovent, Vanceril, Vanceril DSbeclometasone, 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 | Drug | Beclomethasone |
| Placebopatients will receive 8 mL of saline without any drug | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Decrease of the incidence of hoarseness
Time frame: Fifteen minutes after removing the tracheal tube
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: Yes
Related trials for Anesthesia, Endotracheal
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Cavaliere, MD principal investigator
Department cardiovascular diseases A. Gemelli Polyclinic , University Sacred Heart in Rome
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beclomethasone in people with Anesthesia, Endotracheal, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of the incidence of sore-throat. (time frame: Fifteen minutes after removing the tracheal tube). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.