Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000431921
Ethics application status
Approved
Date submitted
23/09/2019
Date registered
1/04/2020
Date last updated
16/07/2021
Date data sharing statement initially provided
1/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The ROX index in the Emergency Department – predicting NIV failure: a prospective observational study
Scientific title
The ROX index in the Emergency Department – predicting NIV failure: a prospective observational study
Secondary ID [1] 299381 0
NIl known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shortness of breath 314551 0
Condition category
Condition code
Emergency medicine 312893 312893 0 0
Resuscitation
Respiratory 313172 313172 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Hours
Description of intervention(s) / exposure
Non-invasive ventilation commenced in the emergency department, as practiced by emergency department clinicians. The researchers will collect routinely recorded patient observations (such as heart rate, respiratory rate, oxygen saturations) in addition to the routinely documented NIV settings, prospectively for any patient commenced on NIV in our ED in order to then calculate the ROX for each patient at specific time stamps. A waiver of consent has been granted from the local ethics committee as the study does not intervene in routinely delivered treatment.

Data from participants will be collected for the duration of their NIV usage, or until it is removed, or 12 hours - whichever may come first.
Intervention code [1] 315642 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321495 0
ROX index value as assessed by comparison to data from routinely collected observations and other patient variable data.
Timepoint [1] 321495 0
12 hours
Primary outcome [2] 323355 0
The utility of the ROX index to predict NIV failure, defined as progression to intubation. Intubation rates will be determined by reviewing hospital records.
Timepoint [2] 323355 0
12 hours
Secondary outcome [1] 375910 0
ROX index data linked to underlying clinical diagnosis as assessed by the final diagnosis on hospital record upon patient discharge. We hope to use the data collected to sub-categories ROX indices for specific pathologies. This will be the same prospectively collected data as already collected.
Timepoint [1] 375910 0
12 hours

Eligibility
Key inclusion criteria
This pragmatic study will include all patients aged 18 or over who are commenced on NIV for breathlessness in the ED, as judged by the treating clinician, regardless of predicted underlying pathology. Breathlessness will be defined by the treating clinician, who will routinely use subjective markers of a patient’s work of breathing as part of clinical assessment, combined with objective data on gas exchange
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior advanced care directive specifying ’not for intubation’
Comorbidities & disease severity where clinician/family provide limitations of care (i.e. not for intubation or ICU)
NIV utilised as a pre-oxygenation strategy with intention to intubate
Patients electively intubated for diagnostic or therapeutic procedures, such as fibreoptic bronchoscopy and surgery

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The predictive capacity of study variables in relation to the primary outcome will be assessed by receiver operating characteristics (ROC) with the ROX index being the a priori predictive variable. The area under the curve (AUROC) and its 95% confidence interval will be reported together with the Youden index for the optimal combination of sensitivity and specificity to predict the primary outcome. Cut-off values for pre-set sensitivities and specificities of 80% and 80% will be used to reflect the degree to which clinicians might accept under- and over-estimation of the predictive capacity of the candidate variable. Variables with a P value <0.2 on ROC analysis will be considered candidates for further statistical evaluation in a binary logistic regression analysis against the dependent variable. The goodness of the fit of the model will be reported by the Hosmer-Lemeshow test and the odds ratios and 95% confidence intervals for any independent variables will be reported. The association between the ROX index and any other independent predictors identified in the logistic regression will be further assessed by Cox proportional hazards modelling with adjustment for the candidate independent variables and reported by the hazard ratio and the 95% confidence interval.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
18/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
113
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303895 0
Self funded/Unfunded
Name [1] 303895 0
Country [1] 303895 0
Primary sponsor type
Hospital
Name
Liverpool Hospital Emergency Department
Address
Liverpool Hospital Emergency Department
Elizabeth Street
Liverpool
NSW
2170
Country
Australia
Secondary sponsor category [1] 304043 0
None
Name [1] 304043 0
Address [1] 304043 0
Country [1] 304043 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304401 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 304401 0
Research Directorate
South Western Sydney Local Health District (SWSLHD)
Locked Bag 7103 Liverpool BC NSW 1871
Ethics committee country [1] 304401 0
Australia
Date submitted for ethics approval [1] 304401 0
Approval date [1] 304401 0
17/05/2019
Ethics approval number [1] 304401 0
2019/ETH09792

Summary
Brief summary
Through the calculation of routinely collected patient data, we hope this study will demonstrate a numerical value which can be used to predict the success or failure of non-invasive ventilation. This is a form of respiratory support given to patients who are short of breath.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96818 0
Dr Samuel Bulford
Address 96818 0
Liverpool Hospital Emergency Department
Liverpool Hospital
Elizabeth Street
Liverpool
NSW
2170
Country 96818 0
Australia
Phone 96818 0
+61427310338
Fax 96818 0
Email 96818 0
[email protected]
Contact person for public queries
Name 96819 0
Samuel Bulford
Address 96819 0
Liverpool Hospital Emergency Department
Liverpool Hospital
Elizabeth Street
Liverpool
NSW
2170
Country 96819 0
Australia
Phone 96819 0
+61427310338
Fax 96819 0
Email 96819 0
[email protected]
Contact person for scientific queries
Name 96820 0
Samuel Bulford
Address 96820 0
Liverpool Hospital Emergency Department
Liverpool Hospital
Elizabeth Street
Liverpool
NSW
2170
Country 96820 0
Australia
Phone 96820 0
+61 427310338
Fax 96820 0
Email 96820 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5044Study protocol    378440-(Uploaded-23-09-2019-23-02-29)-Study-related document.docx



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.