Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000397112
Ethics application status
Approved
Date submitted
5/03/2019
Date registered
12/03/2019
Date last updated
12/02/2021
Date data sharing statement initially provided
12/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases: A randomised multicentre trial
Scientific title
High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases: A randomised multicentre trial
Secondary ID [1] 297614 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 311886 0
endoscopic retrograde cholangiopancreatography 311913 0
Airway management 311955 0
Condition category
Condition code
Oral and Gastrointestinal 310475 310475 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 310496 310496 0 0
Normal development and function of the respiratory system
Anaesthesiology 310531 310531 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM A: High flow nasal cannula, anaesthetist administrating 100% oxygen at a flow rate between 40-70 litres/minute
ARM B: Low flow nasal cannula,anaesthetist administrating oxygen at a flow rate between 2-4 litres/minute, 30-40 % oxygen
Both interventions continue throughout the duration of anaesthesia
Haemodynamic parameters such as oxygen saturation and breathing parameters will be assessed
Intervention code [1] 313851 0
Treatment: Other
Comparator / control treatment
The low flow nasal cannula is the control group
Control group
Active

Outcomes
Primary outcome [1] 319337 0
Occurrence of hypoxia, defined by any event of SpO2 <90%: Proportion of patients experiencing desaturation below 90%
Assessed by pulse oximetry
Timepoint [1] 319337 0
During the course of the anaesthetic
Secondary outcome [1] 367876 0
No of events of desaturation < 90%, assessed as a categorical variable, Yes/No
Any event of desaturation less than 90% will be taken as an outcome
Assessed using pulse oximetry
Timepoint [1] 367876 0
During the anaesthetic course
Secondary outcome [2] 367877 0
Lowest recorded SpO2, assessed from the pulse oximetre readings
Timepoint [2] 367877 0
During the anaesthetic course
Secondary outcome [3] 367878 0
Transcutaneous CO2. Maximum value recorded and average value during the case
Recorded using a CO2 monitor every five minutes till the end of the intervention, and data extracted from the monitor. Maximum value is the highest value noted and an average is calculated
Timepoint [3] 367878 0
During the anaesthetic course
Secondary outcome [4] 367879 0
Requirement of minor airway manoeuvres: jaw lift/jaw thrust, nasopharyngeal airway insertion.
Assessed as per the investigators need to do these, as a categorical outcome, Yes/No
Timepoint [4] 367879 0
During the anaesthetic course
Secondary outcome [5] 367880 0
Requirement of major airway manoeuvres: bag mask ventilation, endotracheal intubation
Assessed as per the investigators need to do these, as a categorical outcome, Yes/No
Timepoint [5] 367880 0
During the anaesthetic course
Secondary outcome [6] 391806 0
Early complications-elicited as patients leave recovery
a. Dry mouth/nose/throat: Binary outcome (constant pain or discomfort in the mouth/nose/throat)
b. Sensation of abdominal bloating: Yes/No

The data is collected as patient-reported outcome as part of the data collection.
Timepoint [6] 391806 0
When the patients leave the post anaesthesia care unit
Secondary outcome [7] 391807 0
Patients' satisfaction score as they leave the post anaesthesia care unit
As a 5 points numerical rating scale:
Very satisfied (5)
Somewhat satisfied (4)
Neither satisfied nor dissatisfied (3)
Somewhat dissatisfied (2)
Very dissatisfied (1)
Timepoint [7] 391807 0
When patient's leave the post anaesthesia recovery room

Eligibility
Key inclusion criteria
Adults (aged over 18 years) fulfilling any of these criteria: ASA 3, or 4, obesity (BMI above 30 kg/m2), obstructive sleep apnoea diagnosed by polysomnography, being treated with CPAP for OSA, or suspected OSA based on STOP BANG greater than or equal to 3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Deemed “difficult airway” and/or difficult intubation based on clinical judgement and known previous difficult airway.
2. Severe cardio-respiratory compromise or any other indications that warrant the procedure to be done under general anaesthesia with endotracheal tube.
3. Patients judged at significant risk of pulmonary aspiration. Risk assessment will be based on patient history (focussing particularly on risk factors for aspiration) and physical examination. Possible risk factors for aspiration include:
a) Increased gastric content, delayed gastric emptying, including lap band in situ, lack of fasting (less than six hours’ solids and two hours for clear fluid).
b) Increased regurgitation risk: Uncontrolled or symptomatic gastro-oesophageal reflux, oesophageal strictures, Zenker Diverticulum and achalasia.
c) Laryngeal incompetence: may be due to cerebral infarct, head injuries, neuromuscular disorders (Parkinson’s disease, Gullian Barre), muscular dystrophies (cerebral palsy, cranial neuropathies).
4. Emergency surgery and any other criteria warranting general anaesthesia with ETT.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation is concealed and it's only revealed prior to randomisation
Allocation is concealed in a sealed opaque envelope, opened just before starting the case
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, done by our our hospital's pharmacy department
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/02/2019
Date of last participant enrolment
Anticipated
1/08/2021
Actual
Date of last data collection
Anticipated
1/08/2021
Actual
Sample size
Target
132
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 13307 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 13308 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 13309 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 25882 0
2305 - New Lambton
Recruitment postcode(s) [2] 25881 0
5000 - Adelaide
Recruitment postcode(s) [3] 25880 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 302157 0
Hospital
Name [1] 302157 0
The Queen Elizabeth Hospital, Department of Anaesthesia
Country [1] 302157 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hopsital Anaesthesia Department
Address
Department of Anaesthesia, The Queen Elizabeth Hospital
28 Woodville Road
Woodville South 5011, South Australia
Country
Australia
Secondary sponsor category [1] 301995 0
None
Name [1] 301995 0
Address [1] 301995 0
Country [1] 301995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302838 0
Central Adelaide Local Health Network Human Research ethics Committee
Ethics committee address [1] 302838 0
Level 3, Roma Mitchell House, 136 North Terrace, Adelaide, South Australia 5000
Ethics committee country [1] 302838 0
Australia
Date submitted for ethics approval [1] 302838 0
10/08/2018
Approval date [1] 302838 0
25/09/2018
Ethics approval number [1] 302838 0
Q20180807

Summary
Brief summary
Endoscopic retrograde cholangiopancreatography (ERCP) is a common intervention in the treatment of biliary and pancreatic diseases, and the demand for ERCP is increasing. There are several difficulties for the anaesthetist to deal with. It is generally performed in a prone or lateral position under moderate to deep sedation or general anaesthesia. The rate of oxygen desaturation could be as high as 11-50%. Both low flow and high flow nasal cannulas are now established ways of delivering oxygen during sedation. It is unclear whether one technique is better than the other. We hypothesis that high flow nasal cannula may provide better oxygen administration and compare these two techniques
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91566 0
Dr Venkatesan Thiruvenkatarajan
Address 91566 0
Department of Anaesthesia, The Queen Elizabeth Hospital
Woodville South 5011, Adelaide, South Australia
Country 91566 0
Australia
Phone 91566 0
+61 0431819763
Fax 91566 0
Email 91566 0
Venkatesan.Thiruvenkatarajan@health.sa.gov.au
Contact person for public queries
Name 91567 0
Dr Venkatesan Thiruvenkatarajan
Address 91567 0
Department of Anaesthesia, The Queen Elizabeth Hospital
Woodville South 5011, Adelaide, South Australia
Country 91567 0
Australia
Phone 91567 0
+61 0431819763
Fax 91567 0
Email 91567 0
Venkatesan.Thiruvenkatarajan@health.sa.gov.au
Contact person for scientific queries
Name 91568 0
Dr Venkatesan Thiruvenkatarajan
Address 91568 0
Department of Anaesthesia, The Queen Elizabeth Hospital
Woodville South 5011, Adelaide, South Australia
Country 91568 0
Australia
Phone 91568 0
+61 0431819763
Fax 91568 0
Email 91568 0
Venkatesan.Thiruvenkatarajan@health.sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data will be confidentially kept by the researchers, it will be decoded and analysed for publication at the end


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4756Study results articleYes Thiruvenkatarajan V, Dharmalingam A, Arenas G, Wah... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHigh-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): Study protocol of a randomised multicentric trial.2020https://dx.doi.org/10.1186/s13063-020-04378-z
N.B. These documents automatically identified may not have been verified by the study sponsor.