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Trial registered on ANZCTR


Registration number
ACTRN12620001013954
Ethics application status
Approved
Date submitted
12/07/2020
Date registered
7/10/2020
Date last updated
28/06/2022
Date data sharing statement initially provided
7/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Perioperative oxygen administration in patients undergoing major non-cardiac surgery under general anaesthesia in Australia and New Zealand: study protocol for a prospective multi-centre observational study.
Scientific title
PRospective Observational Study of perioperative OXygen administration (PROSOX) in patients undergoing major non-cardiac surgery under general anaesthesia in Australia and New Zealand.
Secondary ID [1] 301755 0
None
Universal Trial Number (UTN)
U1111-1255-2165
Trial acronym
PROSOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxia
 318213 0
Hyperoxia 318214 0
Condition category
Condition code
Anaesthesiology 316221 316221 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Inspired oxygen concentration will be obtained from anaesthesia records from the time of ’knife to skin’ FiO2 at 10 minute intervals for the first 120 minutes, and 30 minute intervals for the remaining intraoperative duration until surgical end time.
Intervention code [1] 318051 0
Not applicable
Comparator / control treatment
This is a prospective descriptive study of the patterns of intraoperative oxygen administration by anaesthetists. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324412 0
The primary outcome variable of interest is the proportion of cases where time-weighted average intraoperative inspired oxygen concentration was >/=0.8 in accordance with WHO/CDC guidelines. This will be assessed by reviewing intraoperative anaesthesia records to calculate a time-weighted mean FiO2 administered.
Timepoint [1] 324412 0
Time weighted average intraoperative value during surgery.
Secondary outcome [1] 384569 0
Intraoperative highest FiO2 will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [1] 384569 0
Time-weighted average value during surgery
Secondary outcome [2] 384570 0
Intraoperative highest SpO2 will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [2] 384570 0
Highest recorded value during surgery
Secondary outcome [3] 384571 0
Intraoperative time weighted average PEEP will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [3] 384571 0
Time-weighted average during surgery
Secondary outcome [4] 384572 0
Duration of surgery will be assessed from the intraoperative anaesthesia record.
Timepoint [4] 384572 0
Duration of surgery will be assessed at the completion of surgery from the intraoperative anaesthesia record.
Secondary outcome [5] 385288 0
Intraoperative lowest FiO2 will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [5] 385288 0
Lowest value recorded during surgery
Secondary outcome [6] 385289 0
Intraoperative time weighted average FiO2 will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [6] 385289 0
Time weighted average value recorded during surgery
Secondary outcome [7] 385290 0
Intraoperative median FiO2 will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [7] 385290 0
Median value recorded during surgery
Secondary outcome [8] 385291 0
Intraoperative lowest SpO2 will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [8] 385291 0
Lowest value recorded during surgery
Secondary outcome [9] 385292 0
Intraoperative time weighted average SpO2 will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [9] 385292 0
Time-weighted average of values recorded during surgery
Secondary outcome [10] 385293 0
Intraoperative median SpO2 will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [10] 385293 0
Median value recorded during surgery
Secondary outcome [11] 385294 0
Intraoperative median PEEP will be assessed by reviewing intraoperative anaesthesia records.
Timepoint [11] 385294 0
Median value recorded during surgery

Eligibility
Key inclusion criteria
The anaesthesia events of participating anaesthetists will be eligible for inclusion if all of the following inclusion criteria are met:
1. Patient at least 18 years of age, ASA 3 or 4
2. Non-cardiac surgery performed under general anaesthesia
3. Expected surgical duration of at least 120 minutes and an anticipated postoperative in hospital stay of at least one night
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The anaesthesia event will be excluded if any of the following exclusion criteria are met:
1. Patient is pregnant or receiving supplemental oxygen immediately prior to surgery
2. Site primary investigator view that there exists an indication for or contraindication to specified intraoperative oxygen therapy, which may include but is not limited to severe COPD, previous bleomycin or cisplatin chemotherapy, surgical procedures with a risk of airway fire, and thoracic surgery
3. A prior anaesthesia event already recruited from the individual anaesthetist providing patient care in this study

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary outcome will be reported as the proportion of overall cases with a mean time-weighted intraoperative FiO2 at least 0.8 with 95% confidence intervals. Values for intraoperative oxygen administration will also be reported by site. Continuous secondary outcome data including FiO2, SpO2, PEEP, duration of surgery will be reported as median (IQR) values.

The study sample size calculation is based on a proportion of 6% of anaesthetists administering FiO2 of at least 0.8 to their patients, a desired confidence of 95%, and confidence interval upper limit of less than 10%, giving a total number of 150 required anaesthetists. A finding that fewer than 10% of overall cases have oxygen administered in accordance with the WHO guideline of FiO2 at least 0.8 will be taken as indicating a lack of general support for these guidelines.

Analyses will be reported in accordance with the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) Checklist.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2021
Actual
1/01/2021
Date of last participant enrolment
Anticipated
1/03/2021
Actual
12/12/2021
Date of last data collection
Anticipated
1/04/2021
Actual
12/12/2021
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 17054 0
The Alfred - Melbourne
Recruitment hospital [2] 17055 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 17056 0
Westmead Hospital - Westmead
Recruitment hospital [4] 17057 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 17058 0
Royal Perth Hospital - Perth
Recruitment hospital [6] 17059 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 17060 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [8] 17061 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 30726 0
3004 - Melbourne
Recruitment postcode(s) [2] 30727 0
3050 - Parkville
Recruitment postcode(s) [3] 30728 0
2145 - Westmead
Recruitment postcode(s) [4] 30729 0
5000 - Adelaide
Recruitment postcode(s) [5] 30730 0
6000 - Perth
Recruitment postcode(s) [6] 30731 0
6150 - Murdoch
Recruitment postcode(s) [7] 30732 0
6008 - Subiaco
Recruitment postcode(s) [8] 30733 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 22735 0
New Zealand
State/province [1] 22735 0
Auckland
Country [2] 22736 0
New Zealand
State/province [2] 22736 0
Waikato
Country [3] 22737 0
New Zealand
State/province [3] 22737 0
Wellington
Country [4] 22738 0
New Zealand
State/province [4] 22738 0
Christchurch

Funding & Sponsors
Funding source category [1] 306186 0
Self funded/Unfunded
Name [1] 306186 0
Country [1] 306186 0
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 Commercial Road
Prahran
Victoria 3181
Australia
Country
Australia
Secondary sponsor category [1] 306659 0
Other Collaborative groups
Name [1] 306659 0
Medical Research Institute of New Zealand
Address [1] 306659 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country [1] 306659 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306398 0
New Zealand Southern Health and Disability Ethics Committee
Ethics committee address [1] 306398 0
Ethics committee country [1] 306398 0
New Zealand
Date submitted for ethics approval [1] 306398 0
13/03/2019
Approval date [1] 306398 0
16/04/2019
Ethics approval number [1] 306398 0
19STH66

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103746 0
Dr Daniel Frei
Address 103746 0
Dept of Anaesthesia and Pain Medicine
The Alfred Hospital
55 Commercial Road
Prahran
Victoria 3181
Australia
Country 103746 0
Australia
Phone 103746 0
+61491729402
Fax 103746 0
Email 103746 0
danrfrei@gmail.com
Contact person for public queries
Name 103747 0
Daniel Frei
Address 103747 0
Dept of Anaesthesia and Pain Medicine
The Alfred Hospital
55 Commercial Road
Prahran
Victoria 3181
Australia
Country 103747 0
Australia
Phone 103747 0
+61491729402
Fax 103747 0
Email 103747 0
danrfrei@gmail.com
Contact person for scientific queries
Name 103748 0
Daniel Frei
Address 103748 0
Dept of Anaesthesia and Pain Medicine
The Alfred Hospital
55 Commercial Road
Prahran
Victoria 3181
Australia
Country 103748 0
Australia
Phone 103748 0
+61491729402
Fax 103748 0
Email 103748 0
danrfrei@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data will be shared on request after specific approval from the relevant ethics committees in New Zealand and Australia.
When will data be available (start and end dates)?
From time of study publication until 10 years after data collection.
Available to whom?
Individual participant data will be shared on request with researchers who provide a methodologically sound proposal after approval from the relevant ethics committees in New Zealand and Australia.
Available for what types of analyses?
Individual participant data will be shared on request for any type of data analysis with researchers who provide a methodologically sound proposal after approval from the relevant ethics committees in New Zealand and Australia.
How or where can data be obtained?
Contact with the study lead investigator at danrfrei@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8477Study protocol  danrfrei@gmail.com
8478Statistical analysis plan  danrfrei@gmail.com
8479Informed consent form  danrfrei@gmail.com
8480Ethical approval  danrfrei@gmail.com



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.