ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anaesthesia

endoscopic retrograde cholangiopancreatography

Airway management

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Respiratory

Normal development and function of the respiratory system

Anaesthesiology

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]

Treatment: Other

Comparator / control treatment

The low flow nasal cannula is the control group

Control group

Active

Outcomes

Primary outcome [1]

Occurrence of hypoxia, defined by any event of SpO2 <90%: Proportion of patients experiencing desaturation below 90%
Assessed by pulse oximetry

Timepoint [1]

During the course of the anaesthetic

Secondary outcome [1]

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]

During the anaesthetic course

Secondary outcome [2]

Lowest recorded SpO2, assessed from the pulse oximetre readings

Timepoint [2]

During the anaesthetic course

Secondary outcome [3]

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]

During the anaesthetic course

Secondary outcome [4]

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]

During the anaesthetic course

Secondary outcome [5]

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]

During the anaesthetic course

Secondary outcome [6]

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]

When the patients leave the post anaesthesia care unit

Secondary outcome [7]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW,SA

Recruitment hospital [1]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [2]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [3]

John Hunter Hospital - New Lambton

Recruitment postcode(s) [1]

5011 - Woodville

Recruitment postcode(s) [2]

5000 - Adelaide

Recruitment postcode(s) [3]

2305 - New Lambton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Queen Elizabeth Hospital, Department of Anaesthesia

Address [1]

The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research ethics Committee

Ethics committee address [1]

Level 3, Roma Mitchell House, 136 North Terrace, Adelaide, South Australia 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/08/2018

Approval date [1]

25/09/2018

Ethics approval number [1]

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

Dr Venkatesan Thiruvenkatarajan

Address

Department of Anaesthesia, The Queen Elizabeth Hospital
Woodville South 5011, Adelaide, South Australia

Country

Australia

Phone

+61 0431819763

Fax

[email protected]

Contact person for public queries

Name

Venkatesan Thiruvenkatarajan

Address

Department of Anaesthesia, The Queen Elizabeth Hospital
Woodville South 5011, Adelaide, South Australia

Country

Australia

Phone

+61 0431819763

Fax

[email protected]

Contact person for scientific queries

Name

Venkatesan Thiruvenkatarajan

Address

Department of Anaesthesia, The Queen Elizabeth Hospital
Woodville South 5011, Adelaide, South Australia

Country

Australia

Phone

+61 0431819763

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Thiruvenkatarajan V, Dharmalingam A, Arenas G, Wah... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	High-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.	2020	https://dx.doi.org/10.1186/s13063-020-04378-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically