Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001497493
Ethics application status
Approved
Date submitted
24/10/2016
Date registered
28/10/2016
Date last updated
28/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
“A prospective study to assess the feasibility of High Flow Nasal Oxygen during anaesthesia for Extracorporeal Shock Wave Lithotripsy (ESWL)”
Scientific title
“A prospective study to assess the feasibility of High Flow Nasal Oxygen during anaesthesia for Extracorporeal Shock Wave Lithotripsy (ESWL)”
Secondary ID [1] 290377 0
None
Universal Trial Number (UTN)
U1111-1188-9922
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Stone 300686 0
Condition category
Condition code
Anaesthesiology 300533 300533 0 0
Other anaesthesiology
Renal and Urogenital 300558 300558 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
First successive eligible(based on inclusion and exclusion criteria) 20 patients undergoing ESWL procedure at TPCH from the start of study date and giving informed consent will be included in the study.

All patients in the study will receive the same intervention.

All patients on arrival in theatre will have their baseline vital stats recorded and then subsequently every 5 minutes (or more frequent if required).
The SpO2 probe will be attached and baseline reading on room air recorded.
The trans-cutaneous CO2 monitor is attached for calibration.
The HFNO nasal prongs will be applied at a rate of 70 litres per min for pre-oxygenation.
IV access obtained and other monitoring including ECG, Non invasive BP, Bispectral index and peripheral nerve stimulator monitor attached.
End tidal CO2 level obtained whenever assisted ventilation using the anaesthetic circuit is required during the anaesthetic will be recorded.

Premedication in the form of intravenous midazolam and fentanyl will be given as per choice of the primary anaesthetist in charge of the patient. Intravenous induction of anaesthesia then commenced with propofol target controlled infusion (TCI) based on the Marsh Model to achieve a target BIS between 40-60. When the patient is unconscious and non responsive an appropriate sized Guedels airway will be inserted to ensure upper airway patency throughout the apnoeic period. The patient will be re-positioned as appropriate for the ESWL procedure and then rocuronium @ 0.6 mg/kg will be given for muscle relaxation. The degree of muscle paralysis will be monitored every 5 minutes for further rocuronium top up doses (0.1 mg/Kg) to maintain a paralysis to less than 3 twitches with Train of Four (TOF) count. Additional Fentanyl and Rocuronium doses will be given according to intra operative need as determined by the primary anaesthetist.
The aim of the study is to prove that HFNO can be used as the only mode of ventilation (Oxygenation and removal of carbon dioxide) throughout the procedure and thereby avoid tidal volume ventilation induced movement of kidney to optimise ESWL.
Usually ESWL procedures last for 20-30 minutes as decided by the surgical team.
The HFNO would be ceased and the reminder of the surgery continued using anesthetic circuit and anesthetic ventilator if any of the pre-determined criteria for conversion to default general anesthetic (GA) is reached at any stage (criteria as described below).
Rate of oxygenation used during the entire procedure would be the single level of 70 litres per min and is NOT changed during the procedure or any during any adverse events.
If any adverse event (defined as significant hypoxia =Spo2<90% and/ or hypercarbia = transcutaneous CO2 monitor CO2>65 mmHg) does occur, the anaesthetists will try initially to give normal tidal volume breaths using the anaesthetic circuit and assess the response. If SpO2/ CO2 levels improve to a satisfactory level as determined by the anaesthetic team, then the ESWL will proceed as per study protocol. .
If however,
1)The SpO2/ CO2 levels fails to improve to a satisfactory level as determined by the anaesthetic team
2)Significant hypoxia/hypercarbia (as defined above) recurs frequently (defined as more than once every five minutes) requiring the interruption of the ESWL procedure
3)There is any other associated trends (arrhythmia, hypertension, hypotension) that is concerning for the anaesthetic team
4)The surgeon wants to abort the study for any surgical reason
Then the study will be terminated and the anaesthetic converted to the default conventional anaesthetic.{CONVERSION TO GENERAL ANAESTHETIC]. From this point onwards HFNO is ceased and the ventilation continued using standard anesthetic circuit and anesthetic ventilator.
Once the surgeon confirms the procedure is over, the patients will be hand ventilated using face mask and anaesthetic circuit. EtCO2 levels will be documented.
Propofol TCI will then be ceased and muscle relaxation reversed with appropriate agents (Neostigmine or sugammadex) depending on degree of residual muscle paralysis.
All perioperative measurements will be observed and documented in the study data collection form as described below-The aim is to capture as much information as possible regarding the intra operative period. The relevance of various data collected will be discussed at the end of the study and will help formulate a well written study protocol for the future RCT.
Demographic data: age, gender, weight, height, BMI.
Surgical data details: details of stone (position, number, size, side, type if known) and previous treatment history.
Procedure duration details: anaesthetic and surgical start and finish time.
(Anaesthetic start time= Patient on operating table and ready to start.
Anaesthetic finish time=Patient ready to be transferred the post anaesthesia care unit (PACU) [anaesthetic readiness, irrespective of PACU bed availability)
(Surgical start time= time after patient positioning coinciding with the first shock delivered.
Surgical finish time = time when last shock is delivered)
Procedure details: total number of shocks, total energy (joules),delivered operating theatre time, number of x-rays exposures/screening done, degree of stone movement as measured by fluoroscopy.
Anaesthesia details: Baseline and every 5 minute vital statistics in the form of heart rate, systolic and diastolic blood pressure, peripheral pulse saturation level, trans cutaneous CO2 levels, Bispectral index (BIS), train of four counts to assess depth of neuromuscular blockade, propofol TCI levels, HFNO flow level, opioid and other sedation used, drug and dosage of any other drugs used including any vasoactive drugs and details of any other intra or post op adverse events or anaesthetic intervention.
[The Primary and secondary end points are the only 3 end points as described under the Endpoints section. The data collection form instructs the investigator to capture as much information as possible regarding the peri operative period of this initial pilot study. The relevance of each individual data collected will be discussed at the end of the study. This additional safety step is included in the study protocol to help formulate a well written study protocol for the future planned RCT.
Please note that any relevant additional parameters recorded by the investigator during the study such as incidence of hypertension, arrhythmias or any unanticipated hospital re-admission, etc. are not assessed as secondary outcomes for the study and hence are not included as secondary end points.]
Intervention code [1] 296203 0
Treatment: Devices
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299953 0
Primary end point= Rate of conversion to conventional anesthesia.

The number of cases out of the total 20 study patients which are converted to general anesthesia (GA) is the primary end point.

If any adverse event (defined as significant hypoxia =pulse oximeter SpO2 <90% and significant hypercarbia =transcutaneous CO2 monitor CO2 >65 mmHg)) does occur, the anesthetists will try initially to give normal tidal volume breaths using the anesthetic circuit and assess the response. If SpO2/ CO2 levels improve to a satisfactory level as determined by the anesthetic team, then the ESWL will proceed as per study protocol.

If however,

1)the SpO2/ CO2 levels fails to improve to a satisfactory level as determined by the anesthetic team
2)significant hypoxia/hypercarbia (as defined) recurs frequently (more than once every five minutes) requiring the interruption of the ESWL procedure
3)there is any other associated trends (arrhythmia, hypertension, hypotension) that is concerning for the anesthetic team
4)the surgeon wants to abort the study for any surgical reason

Then the study will be terminated and the anesthetic converted to the default conventional anesthetic.(defined as case CONVERTED TO GENERAL ANESTHESIA)
Timepoint [1] 299953 0
Intraoperative period : from anesthetic start to finish time
(Anesthetic start time= Patient on operating table and ready to start
Anaesthetic finish time=Patient ready to go to post anesthesia care unit)
Secondary outcome [1] 328641 0
Incidence of significant hypoxia requiring intervention


(significant hypoxia defined as pulse oximeter measured SpO2 <90% )
Timepoint [1] 328641 0
Intraoperative period : from anesthetic start to finish time

(Anesthetic start time= Patient on operating table and ready to start
Anaesthetic finish time=Patient ready to go to post anesthesia care unit)
Secondary outcome [2] 328733 0
Incidence of significant hypercarbia requiring intervention

(significant hypercarbia is defined as transcutaneous CO2 >65 mmHg measured using transcutaneous CO2 monitor)

[The secondary end points are the only 2 end points as described under the Secondary Endpoints section. The data collection form allows the investigator to capture as much information as possible regarding the peri operative period to ensure that as much information as possible is recorded during this initial pilot study. The relevance of each individual data collected will be discussed at the end of the study. This additional safety step is included in the study protocol to help formulate a well written study protocol for the future planned RCT.
Please note that the additional parameters recorded for the study such as hypertension, arrhythmias, any unanticipated hospital re-admission,etc. are not assessed as secondary outcomes for the study and hence are not included as secondary end points.]
Timepoint [2] 328733 0
Intraoperative period : from anesthetic start to finish time

(Anesthetic start time= Patient on operating table and ready to start
Anaesthetic finish time=Patient ready to go to post anesthesia care unit)

Eligibility
Key inclusion criteria
Age > or equal to 18 years
ASA Grade I or II
Undergoing elective ESWL procedure
Able to provide informed consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inadequate English language comprehension due to a language barrier
Cognitive deficit or disability
BMI >35
Anticipated /known difficult airway
History of severe respiratory disease
History of OSA requiring use of CPAP device
History of recent oro- maxillofacial trauma
History of symptomatic gastroesophageal reflux disease (GORD) despite therapy
Any history that will warrant the use of a definitive airway for airway protection
Women who are pregnant
Children and/or young people (ie. <18 years)
People highly dependent on medical care
People with a cognitive impairment, an intellectual disability or a mental illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable as not a RCT
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis
Sample size: This is a pilot study which will generate data to calculate sample size numbers for a possible RCT in the future. This study will include 20 patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2016
Actual
Date of last participant enrolment
Anticipated
1/06/2017
Actual
Date of last data collection
Anticipated
1/06/2017
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6860 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 14525 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 294771 0
Hospital
Name [1] 294771 0
The Prince Charles Hospital
Country [1] 294771 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
Australia
Country
Australia
Secondary sponsor category [1] 293616 0
None
Name [1] 293616 0
Address [1] 293616 0
Country [1] 293616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296177 0
Human Research Ethics Committee
Ethics committee address [1] 296177 0
The Prince Charles Hospital
Human Research Ethics Committee
The Prince Charles Hospital
Building 14
Rode Road, Chermside QLD 4032
Ethics committee country [1] 296177 0
Australia
Date submitted for ethics approval [1] 296177 0
24/08/2016
Approval date [1] 296177 0
12/10/2016
Ethics approval number [1] 296177 0
HREC/16/QPCH/282

Summary
Brief summary
Conventional anaesthesia for Extracorporeal Shockwave Lithotripsy [ESWL] requires ventilation, which results in movement of the kidney during inspiration and expiration. This cause the stone to move out of the focal point of the shockwaves for a significant percentage of treatment time resulting in prolonged operating time and also potential injury to the adjacent normal renal tissue. It is hypothesised that if the patient could remain apnoeic during treatment the majority of energy delivered will be focused on the target with minimal wastage and less adjacent tissue damage.
Previous studies have suggested that if the patient could remain apnoeic during the treatment almost all the energy delivered will be transmitted directly on to the stones resulting in more effective treatment. Multiple studies based on this idea have been published in major peer reviewed journals describing methods like high frequency jet ventilation (HFJV) for ventilating patients with minimal diaphragmatic movement. These studies have demonstrated that such ventilation modes result in significantly fewer total shocks than with conventional mechanical ventilation. However HFJV requires additional expertise, poses a further range of risks and side effects and also requires special equipment currently not available at The Prince Charles Hospital (TPCH).
High-Flow Nasal Oxygen [HFNO] recently introduced at TPCH, offers a novel method of providing oxygenation during extended periods of apnoea. Multiple studies have proven HFNO as a safe and beneficial method of improving oxygenation and carbon dioxide (CO2) removal in patients with impaired respiratory function or after a period of mechanical respiratory support on a breathing machine.
The researchers hypothesise that the usage of HFNO during ESWL will allow a clinically relevant period of apnoea resulting in more effective treatment, fewer shocks and a shorter duration of treatment. The multi factorial benefits can only be completely elucidated by a large prospective randomised controlled trial.
The proposed research activity is a pilot study to investigate the feasibility of safe provision of anaesthesia for ESWL using HFNO. It aims to identify potential problems and to help plan and write up a robust methodology for the proposed larger RCT in the future.
This study will be a prospective study in 20 patients undergoing elective ESWL at The Prince Charles Hospital [TPCH], who fulfil the inclusion/exclusion criteria and give informed consent to participate. All relevant peri-operative events, all standard patient parameters including routinely monitored vital statistics and any necessary optimisation steps initiated to ensure safe provision of anaesthesia during ESWL will be recorded and analysed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69866 0
Dr Shakeel Meeran Kunju
Address 69866 0
Department of Anesthesia
The Prince Charles Hospital
Level 1
Rode Road, Chermside QLD 4032
Country 69866 0
Australia
Phone 69866 0
+61-7-3139 4000
Fax 69866 0
Email 69866 0
[email protected]
Contact person for public queries
Name 69867 0
Dr Shakeel Meeran kunju
Address 69867 0
Department of Anesthesia
The Prince Charles Hospital
Level 1
Rode Road, Chermside QLD 4032
Country 69867 0
Australia
Phone 69867 0
+61-7-3139 4000
Fax 69867 0
Email 69867 0
[email protected]
Contact person for scientific queries
Name 69868 0
Dr Shakeel Meeran Kunju
Address 69868 0
Department of Anesthesia
The Prince Charles Hospital
Level 1
Rode Road, Chermside QLD 4032
Country 69868 0
Australia
Phone 69868 0
+61-7-3139 4000
Fax 69868 0
Email 69868 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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