Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000983101
Ethics application status
Approved
Date submitted
25/06/2019
Date registered
10/07/2019
Date last updated
9/12/2020
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
High-flow nasal oxygen vs standard care to prevent low oxygen levels during gastroscopy.
Scientific title
Gastroscopy Oxygen delivery: Standard care vs THRIVE to prevent desaturation - a randomised controlled trial
Secondary ID [1] 298599 0
None
Universal Trial Number (UTN)
U1111-1235-9578
Trial acronym
GOST (Gastroscopy Oxygen delivery: Standard care vs THRIVE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroscopy 313448 0
Condition category
Condition code
Anaesthesiology 311884 311884 0 0
Anaesthetics
Oral and Gastrointestinal 311996 311996 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High flow humidified nasal oxygen. Oxygen administered via the Optiflow THRIVE device to patient via soft prongs inserted in the nose, at a flow rate of 50-70 L/min as tolerated, humidified using the Fisher and Paykel 850 humidifier, to a humidity of 70% relative humidity. The oxygen concentration delivered from the device will be 100%, but the actual inspired oxygen concentration will vary with the patient's inspiratory flow rate and degree of air entrainment.

In the intervention group, patients will be put on a THRIVE device with oxygen delivering at 30 L/min immediately upon entering the room, but before sedation administration. The oxygen delivering rate will be increased to 70 L/min via the THRIVE device immediately after sedation agent is given and will be maintained at 70 L/min during the procedure. The flow rate can be increased up to 100 L/min if necessary by the anaesthetist or decreased to 30L/min if patient is not tolerating the device.

Each gastroscopy procedure will be monitored by an observer who will be recording clinical information on a standardised case report form. All departures from protocol will be noted on this form.

The gastroscopy procedure will only commence once a clinically appropriate level of sedation is reached, titrated by the anaesthetist. As such, oxygen administration will have occurred for a minimum of 3-5 minutes before the procedure begins.

Oxygen delivery will continue until the conclusion of the gastroscopy procedure, and will be removed when the patient is stable for transfer to the recovery room, as judged by the anaesthetist. Typically gastroscopy lasts 5-10 minutes, so in most cases patients will receive the intervention for 8-15 minutes.
Intervention code [1] 314859 0
Treatment: Devices
Comparator / control treatment
Standard oxygen therapy. Oxygen administered at 4-10 L/min via nasal cannulae, as per the regular practice at the Royal Melbourne Hospital in accordance with ANZCA Professional Standards PS09: "Guidelines on Sedation and/or Analgesia for Diagnostic and Interventional Medical, Dental or Surgical Procedures".
Control group
Active

Outcomes
Primary outcome [1] 320548 0
Proportion of patients experiencing desaturation (SpO2 below 90%) as measured by pulse oximetry.
Timepoint [1] 320548 0
SpO2 will be monitored continuously during anaesthesia for gastroscopy. Any SpO2 reading lower than 90% will be counted as an event. Events will be recorded by an observer present during the procedure on a standardised case report form.
Secondary outcome [1] 371973 0
Number of hypoxic episodes (SpO2 below 90%) during the procedure as measured by pulse oximetry.
Timepoint [1] 371973 0
SpO2 will be monitored continuously during procedure.
Secondary outcome [2] 371974 0
Lowest SpO2 during procedure as assessed by pulse oximetry
Timepoint [2] 371974 0
SpO2 will be monitored continuously during the procedure.
Secondary outcome [3] 371976 0
Number of interruptions to procedure to allow anaesthetic management, such as bag-mask ventilation, insertion of an LMA, intubation or other rescue airway procedure. Recorded by observer on standardised case report form for each procedure.
Timepoint [3] 371976 0
Monitored continuously during procedure.
Secondary outcome [4] 371977 0
Total time for procedure measured from the start of oxygenation until the end of oxygenation, using digital stop watch.
Timepoint [4] 371977 0
At conclusion of procedure
Secondary outcome [5] 371978 0
Patient satisfaction score as assessed with a Likert scale (0-5)
Timepoint [5] 371978 0
Once patient has recovered from anaesthesia, typically 1-4 hours post-procedure. At most this can be up to the point of discharge from the day procedure.
Secondary outcome [6] 371979 0
Proceduralist satisfaction score as reported using a Likert scale (0-5).
Timepoint [6] 371979 0
At conclusion of procedure
Secondary outcome [7] 371980 0
Anaesthetists satisfaction score as reported using a Likert scale (0-5).
Timepoint [7] 371980 0
At conclusion of procedure
Secondary outcome [8] 371981 0
Any other complications, such as arrhythmia, myocardial ischaemia and cardiac arrest as identified by the treating anaesthetist.
Timepoint [8] 371981 0
Any complication occurring during procedure
Secondary outcome [9] 371982 0
Maximum oxygen delivering rate (L/min) as selected on the oxygen flow-meter.
Timepoint [9] 371982 0
Monitored continuously during procedure
Secondary outcome [10] 371983 0
Minimum oxygen delivering rate (L/min) as selected on the oxygen flow-meter.
Timepoint [10] 371983 0
Monitored continuously during procedure

Eligibility
Key inclusion criteria
Adults able to give informed consent requiring sedation for gastroscopy AND one or both of:
- BMI > 30
- Weight > 100kg
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age < 18 years
- Unable to consent
- Intubated or requiring intubation for procedure
- Pregnant
- Active nasal bleed
- Base of skull fracture
- Planned for ERCP procedure

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)
Allocation concealed by central computer-generated randomisation prior to therapy initiation but after eligibility screening.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer - generated.
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
Fisher-exact test or Chi-square test will be used for non-parametric data. Unpaired two-tailed t-test or Mann Whitney U-test will be used for parametric data. Confidence intervals around incidence of desaturation, and the effect size will be calculated.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
13/01/2020
Actual
13/02/2020
Date of last participant enrolment
Anticipated
13/02/2022
Actual
17/03/2020
Date of last data collection
Anticipated
13/02/2022
Actual
Sample size
Target
150
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14098 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 26889 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 303141 0
Hospital
Name [1] 303141 0
Royal Melbourne Hospital
Country [1] 303141 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan Street, Parkville, Victoria 3050
Country
Australia
Secondary sponsor category [1] 303138 0
None
Name [1] 303138 0
Address [1] 303138 0
Country [1] 303138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303690 0
Melbourne Health HREC
Ethics committee address [1] 303690 0
The Royal Melbourne Hospital
300 Grattan Street, Parkville, Victoria 3050
Ethics committee country [1] 303690 0
Australia
Date submitted for ethics approval [1] 303690 0
31/07/2019
Approval date [1] 303690 0
07/01/2020
Ethics approval number [1] 303690 0

Summary
Brief summary
Gastroscopy is a very common medical procedure undertaken to screen, diagnose and treat diseases of the upper gastrointestinal tract. Patients are sedated to allow them to tolerate the procedure but this carries a risk of low oxygen levels during the gastroscopy; this is more common in patients with higher body mass index. In order to protect against low oxygen levels, patients are normally given supplemental oxygen via the nose during gastroscopy. This project is comparing the normal way of giving oxygen versus a system that delivers high-flow, warmed, humidified oxygen (the Optiflow THRIVE device), for patients undergoing gastroscopy who have a body mass index greater than 30 or who weigh more than 100 kilograms. The hypothesis is that in these patients, high-flow, humidified nasal oxygen will reduce the incidence of desaturation (oxygen levels < 90%) versus the standard of care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94502 0
Dr Irene Ng
Address 94502 0
Royal Melbourne Hospital
Department of Anaesthesia and Pain Management
Grattan St
Parkville
Victoria
3050
Country 94502 0
Australia
Phone 94502 0
+61393427000
Fax 94502 0
Email 94502 0
[email protected]
Contact person for public queries
Name 94503 0
Dr Ned Douglas
Address 94503 0
The Royal Melbourne Hospital
Department of Anaesthesia and Pain Management
Grattan St
Parkville
Victoria
3050
Country 94503 0
Australia
Phone 94503 0
+61393427000
Fax 94503 0
Email 94503 0
[email protected]
Contact person for scientific queries
Name 94504 0
Dr Irene Ng
Address 94504 0
Royal Melbourne Hospital
Department of Anaesthesia and Pain Management
Grattan St
Parkville
Victoria
3050
Country 94504 0
Australia
Phone 94504 0
+61393427000
Fax 94504 0
Email 94504 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


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.