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Trial registered on ANZCTR


Registration number
ACTRN12615001198516
Ethics application status
Approved
Date submitted
23/07/2015
Date registered
4/11/2015
Date last updated
4/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
General anesthesia for bronchial thermoplasty in patients with severe, persistent asthma - description of a protocol
Scientific title
General anesthesia for bronchial thermoplasty in patients suffering from severe, persistent asthma- impact on perioperative respiratory stability and operator comfort.
Secondary ID [1] 287404 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General Anesthesia 295386 0
Asthma 295387 0
Bronchial thermoplasty 295388 0
Condition category
Condition code
Anaesthesiology 295649 295649 0 0
Other anaesthesiology
Respiratory 295650 295650 0 0
Asthma
Surgery 295651 295651 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Bronchial thermoplasty consists of controlled delivery of radiofrequency electrical energy to the bronchial wall which heats up the tissue thus reducing the amount of smooth muscle present in the airway. The result is a diminished potential for bronchoconstriction and long-lasting improvement of asthma symptoms.
The treatment is divided into 3 sessions lasting approximately 1 hour, 3 weeks apart. In our centre bronchial thermoplasty is performed in the operating theatre by the pneumologist , with the patient under general anaesthesia irrespective of enrolement in this trial.
Patients are premedicated with 0.5 mg of Alprazolam orally one hour before the procedure. Non-invasive monitoring consisting of pulse oxymetry, ECG , blood pressure and neuromuscular monitoring is placed and peripheral venous access is obtained on arrival in the operating room.
General anaesthesia is induced with Remifentanyl 0.5 micrograms /kg/min for 5 min then 0.15-0.25 micrograms/kg/min, Lidocaine 1 mg/kg, Propofol TCI( Marsh model) for a target concentration above 2 micrograms/ml and Rocuronium 0.6 mg/kg. A laryngeal mask airway(LMA Ambu Registered Trademark AuraGain Trademark) is inserted under deep anaesthesia ,the gastric content is aspirated via the dedicated port and pressure controlled mechanical ventilation is initiated. A radial artery catheter is placed and a blood gas analysis is performed before the beginning of the procedure and then every 15 min during the thermoplasty session. Adjuncts to the anaesthesia are used in order to minimise bronchospasm and/or oedema related to the airway instrumentation: Magnesium sulphate 2g iv in 30 min, Methylprednisolone 125 mg iv and Adrenaline 0.5 mg subcutaneously after the induction of general anaesthesia. Once the area to treat is identified by fiberoptic bronchoscopy the thermoplasty electrode is guided into place via the LMA and the procedure begins.
Curarisation is maintained by supplementary boluses of Rocuronium 0.15 mg/kg. Paracetamol iv 15 mg/kg, Tramadol 1 mg/kg and Alizapride 1 mg/kg are administered 30 min before the end of the procedure.
Neuromuscular blockade is reversed with Sugammadex once the session is over ,Remifentanyl and Propofol infusions are stopped and the LMA is removed once spontaneous breathing is restored. The patient is monitored in the Post Anaesthesia Care Unit(PACU) for two hours before discharge to the ward. Bronchodilator aerosols are administered to control bronchospasm if present and Piritramide is titrated to control pain. Blood gas samples are analysed on arrival and at the end of the PACU stay.
Intervention code [1] 292143 0
Not applicable
Comparator / control treatment
NIL
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295362 0
Respiratory stability as assessed by tidal volume, peak inspiratory pressure, peripheral capillary oxygen saturation(SpO2), fraction of inspired oxygen(FiO2), partial pressure of oxygen in the arterial blood(PaO2), partial pressure of carbon dioxide in the arterial blood and end tidal carbon dioxide concentration(EtCO2)
Timepoint [1] 295362 0
At baseline and every 2 minutes intraoperatively for SpO2, FiO2, tidal volume, peak inspiratory pressure and EtCO2. At baseline and every 15 minutes intraoperatively for PaO2 et PaCO2
Primary outcome [2] 295363 0
Operator satisfaction as assesed by the total duration of the thermoplasty session and the cumulated pause time needed for optimisation of patient’s respiratory status if desaturation, cough or air leaks occur.
Timepoint [2] 295363 0
From start of thermoplasty session as defined by the first delivery of the radiofrequency current to the first bronchus to treat to the end of the session defined by the last activation of the thermoplasty device.
Secondary outcome [1] 315428 0
Hemodynamic stability as assessed by heart rate and blood pressure measured invasively via a radial artery catheter.
Timepoint [1] 315428 0
At baseline and every 2 minutes intraoperatively.
Secondary outcome [2] 315429 0
The need for bronchodilators as assessed by the total dose of Duovent and adrenaline aerosols
Timepoint [2] 315429 0
From arrival until 2 hours after arrival in the post anesthesia care unit.
Secondary outcome [3] 315430 0
Thoracic pain as assessed by Visual Analogue Scale
Timepoint [3] 315430 0
Every 5 minutes during the 2 hour stay in the Post Anesthesia Care Unit

Eligibility
Key inclusion criteria
Adults suffering from severe persistent asthma scheduled for bronchial thermoplasty under general anesthesia
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suspicion of pregnancy confirmed by beta HCG dosage

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6987 0
Belgium
State/province [1] 6987 0

Funding & Sponsors
Funding source category [1] 291507 0
Self funded/Unfunded
Name [1] 291507 0
Address [1] 291507 0
Country [1] 291507 0
Primary sponsor type
Hospital
Name
CHU Dinant-Godinne
Address
Avenue Gaston Therasse 1
5530 Yvoir
Country
Belgium
Secondary sponsor category [1] 290187 0
None
Name [1] 290187 0
Address [1] 290187 0
Country [1] 290187 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293047 0
Comite d’Ethique Medicale du CHU Dinant-Godinne
Ethics committee address [1] 293047 0
Avenue Gaston Therasse 1
5530 Yvoir
Ethics committee country [1] 293047 0
Belgium
Date submitted for ethics approval [1] 293047 0
Approval date [1] 293047 0
22/04/2015
Ethics approval number [1] 293047 0

Summary
Brief summary
Bronchial thermoplasty is a new treatment modality for severe, persistent asthma that delivers thermal energy to the airway wall resulting in a prolonged reduction in airway smooth muscle mass. It’s a procedure performed during bronchoscopy, usually under light sedation . General anesthesia and mechanical ventilation of the patient might improve the overall safety of the procedure. The aim of this study is to evaluate respiratory and hemodynamic stability of asthmatic patients who undergo bronchial thermoplasty under general anesthesia as well as operator and patient comfort.
Trial website
Trial related presentations / publications
Public notes
The first patient benefiting from bronchial thermoplasty in our hospital was scheduled for december 2014 and for safety reasons the procedure was performed under general anesthesia, with an anesthesia protocole adapted for asthmatic patients undergoing interventional bronchoscopy procedures. That protocole was submitted to the ethics commitee, but the approval came after the first patient was treated. However the protocole remained the same throughout the recruitment period and informed consent was obtained for all the patients.

Contacts
Principal investigator
Name 58230 0
Dr Vornicu Ovidiu Ionut
Address 58230 0
Avenue Gaston Therasse 1
5530 Yvoir
Country 58230 0
Belgium
Phone 58230 0
+3281423947
Fax 58230 0
+3281423920
Email 58230 0
ovidiu.vornicu@uclouvain.be
Contact person for public queries
Name 58231 0
Dr Vornicu Ovidiu Ionut
Address 58231 0
Avenue Gaston Therasse 1
5530 Yvoir
Country 58231 0
Belgium
Phone 58231 0
+3281423947
Fax 58231 0
+3281423920
Email 58231 0
ovidiu.vornicu@uclouvain.be
Contact person for scientific queries
Name 58232 0
Prof Mayne Alain
Address 58232 0
Avenue Gaston Therasse 1
5530 Yvoir
Country 58232 0
Belgium
Phone 58232 0
+3281423915
Fax 58232 0
+3281423920
Email 58232 0
alain.mayne@uclouvain.be

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary