Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000404729
Ethics application status
Approved
Date submitted
10/04/2013
Date registered
12/04/2013
Date last updated
24/07/2019
Date data sharing statement initially provided
24/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tolerance and Efficacy of Extubation to Nasal Oxygen in women undergoing surgery
Scientific title
A randomised trial investigating the tolerance and efficacy of nasal versus facemask oxygen in patients undergoing surgery requiring intubation, whom are at risk of haemoglobin desaturation.
Secondary ID [1] 282279 0
Nil
Universal Trial Number (UTN)
Trial acronym
TEETOTAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxaemia in anaesthesia 288836 0
Condition category
Condition code
Anaesthesiology 289192 289192 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extubation to nasal prong oxygen at 6L/min versus facemask oxygen at 6 L/min. From extubation until discharge from recovery ward (approximately for 1 hour).
Intervention code [1] 286920 0
Treatment: Devices
Comparator / control treatment
Active control being facemask oxygen at 6L/minute (normal practise). From extubation until discharge from recovery ward (approximately 1 hour).
Control group
Active

Outcomes
Primary outcome [1] 289300 0
Comfort/ tolerance rated as a cumulative score by patient/ theatre nurse/ recovery ward nurse. Rated on 100mm Visual Analogue Scale (VAS).
Timepoint [1] 289300 0
Patient will assess comfort/ tolerance at discharge from recovery ward (for their conscious time post anaesthetic). Approximately at 1 hour post extubation.
Theatre nurse will assess comfort/ tolearnce at 1 minute post extubation.
Recovery ward nurse will rate comfort/ tolerance for the duration of time in recovery at the time of dischrge from recovery ward. Approximately 1 hour post extubation.
Secondary outcome [1] 302188 0
Number of attempted or actual removal of oxygen delivery device by the patient.
Timepoint [1] 302188 0
Cummulatively from extubation until discharge from recovery ward. 1 minute post extubation until approximately 1 hour post.
Secondary outcome [2] 302189 0
Time from extubation until discharge criteria from recovery ward met
Timepoint [2] 302189 0
This would be expected to be 30 minutes until 1 hour post extubation.
Secondary outcome [3] 302190 0
Need for intervention:
Anaesthetic circuit and mask
Application of PEEP
Additional oxygen
Timepoint [3] 302190 0
Time is recorded if any of these outcomes occur. These could occur at any time from time of extubation until approximately one hour post extubation. They are most likely to occur in the first 20 minutes post extubation.
Secondary outcome [4] 302191 0
Minimum recorded haemoglobin oxygen saturation as recorded using a digital pulse oximeter.
Timepoint [4] 302191 0
Pulse oximetry will be recorded for the duration of the study. This is expected to be from extubation until approximately 1 hour post.

Eligibility
Key inclusion criteria
Patients undergoing surgery
General anaesthesia requiring intubation
One of the following:
BMI > 30
Regular Smoker
Respiratory disease limiting exercise or requiring regular medication
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal or withdrawal of consent
Ischaemic heart disease
Cerebrovascular disease
Pregnancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolled by research nurse
Randomised by computer (pre allocated into envelopes)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
10/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 861 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 6675 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 287069 0
Self funded/Unfunded
Name [1] 287069 0
Country [1] 287069 0
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital for Women
Address
Bagot Road
Subiaco, 6008
Western Australia
Country
Australia
Secondary sponsor category [1] 285844 0
None
Name [1] 285844 0
Address [1] 285844 0
Country [1] 285844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289086 0
Women and Newborn Health Service
Ethics committee address [1] 289086 0
King Edward Memorial Hospital for Women
374 Bagot Road,
Subiaco, 6008
WA
Ethics committee country [1] 289086 0
Australia
Date submitted for ethics approval [1] 289086 0
01/10/2012
Approval date [1] 289086 0
05/02/2013
Ethics approval number [1] 289086 0
2078/EW

Summary
Brief summary
To see the tolerance patients have after a general anaesthetic of nasal oxygen as opposed to facemask oxygen (which is normal). Previous studies show that compliance with oxygen therapy is better with nasal oxygen than facemask oxygen. Also we believe this technique gives patients as effective oxygenation. Therefore potentially improving patient safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39126 0
Dr Edward Debenham
Address 39126 0
Department of Anaesthesia
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
Western Australia 6008
Country 39126 0
Australia
Phone 39126 0
61 (8) 9340 2222
Fax 39126 0
Email 39126 0
[email protected]
Contact person for public queries
Name 39127 0
Edward Debenham
Address 39127 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
Western Australia 6008
Country 39127 0
Australia
Phone 39127 0
61 (8) 9340 2222
Fax 39127 0
Email 39127 0
[email protected]
Contact person for scientific queries
Name 39128 0
Edward Debenham
Address 39128 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
Western Australia 6008
Country 39128 0
Australia
Phone 39128 0
61 (8) 9340 2222
Fax 39128 0
Email 39128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not done


What supporting documents are/will be available?

No Supporting Document Provided



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.