Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001167853
Ethics application status
Approved
Date submitted
15/06/2021
Date registered
27/08/2021
Date last updated
15/05/2024
Date data sharing statement initially provided
27/08/2021
Date results information initially provided
15/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Nasal High Flow Therapy for Respiratory Support in the Emergency Department, a Point Prevalence Study
Scientific title
Nasal High Flow Therapy for Respiratory Support and the need for escalation of care in the Emergency Department, a Point Prevalence Study
Secondary ID [1] 302911 0
None
Universal Trial Number (UTN)
U1111-1262-0861
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Requirement for Respiratory Support 319922 0
Condition category
Condition code
Emergency medicine 317864 317864 0 0
Other emergency care
Respiratory 320269 320269 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nasal High Flow therapy delivered via a nasal interface :
Heated and humidified gas flow rates from 5- 60 L/min
FiO2 21- 100%
Temperature 32-37 C
Patients will receive this therapy regardless of whether they are enrolled in the study or not, and at the discretion of their clinicians
Only data from clinical records shall be collected ie there is no additional involvement for patients
The duration of patient involvement is 30 days post ED admission
The data will be collected in 2 , 12 hour cross sections of time separated by 4 weeks
The data sources are from within 4 EDs within 4 District Area Health Boards (DHBs) in NZ
Intervention code [1] 319193 0
Diagnosis / Prognosis
Comparator / control treatment

Participants admitted to the ED who are treated with any of the following individual therapies or a combination of these, without Nasal High Flow therapy:
Conventional low flow O2 < 15L/min via a mask or nasal cannula (COT)
Bi-Level Positive airway pressure( BiPAP)
Continuous Positive Airway Pressure (CPAP)
Noninvasive ventilation (NIV)
Invasive Positive Pressure Ventilation IPPV
Control group
Active

Outcomes
Primary outcome [1] 325876 0
Requirement for escalation of care assessed by data linkage to clinical records
Timepoint [1] 325876 0
During this admission to ED
Primary outcome [2] 325877 0
Adverse event rate for example cardiac or respiratory arrest
As determined from clinical records
Timepoint [2] 325877 0
During this admission to ED
Primary outcome [3] 325878 0
Mortality
Timepoint [3] 325878 0
For the duration of hospital admission up to 30 days, or up to 30 days post-enrolment including post-hospital discharge
Secondary outcome [1] 389408 0
Discharge destination as determined from clinical records
Timepoint [1] 389408 0
During this admission to ED
Secondary outcome [2] 389409 0
Hospital length of stay, as determined from clinical records
Timepoint [2] 389409 0
During this admission to hospital
Secondary outcome [3] 392532 0
ED length of stay, as determined from clinical records
Timepoint [3] 392532 0
During this admission to ED
Secondary outcome [4] 392533 0
Type of Respiratory Support (RS) delivered in ED, as determined from clinical records
Timepoint [4] 392533 0
During this ED admission
Secondary outcome [5] 392537 0
Duration of RS delivered in the ED as determined in the clinical records

Timepoint [5] 392537 0
During this ED admission
Secondary outcome [6] 398512 0
NHF flow rate as determined from clinical records
Timepoint [6] 398512 0
Whilst on NHF
Secondary outcome [7] 398513 0
NHF FiO2 as determined from clinical records
Timepoint [7] 398513 0
Whilst on NHF
Secondary outcome [8] 398514 0
Respiratory rate as determined from clinical records
Timepoint [8] 398514 0
Whilst on NHF
Secondary outcome [9] 398515 0
Triage score as determined from clinical records
Timepoint [9] 398515 0
On admission to ED
Secondary outcome [10] 398516 0
EWS score as determined from clinical records
Timepoint [10] 398516 0
In ED
Secondary outcome [11] 398517 0
SpO2 as determined from clinical records
Timepoint [11] 398517 0
Whilst on NHF

Eligibility
Key inclusion criteria
Adult Emergency Department Patient
Requirement for any form or combination of respiratory support (via COT, NIV, NHF, BiPaP, CPAP , nebuliser , and or IPPV)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No requirement for respiratory support

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
No, a priori sample size was calculated- this is a convenience sample of participants presenting within two 12 hour periods within one week.
A descriptive analysis of the data will be carried out.
Statistical analysis will be performed using statistical software (R).
To determine the prevalence of escalation, each qualifying patient episode will be counted as one escalation.
Data regarding multiple escalations will be collected and presented descriptively.
Appropriateness and use of inferential statistical analyses will depend on the final sample size of the cohorts.
The main outcomes will be analysed by using regression models.
Expressly, dichotomous outcome data (a requirement for escalation, mortality) will be analysed using logistic regression. In contrast, categorical or continuous data (type of RS therapy received, ED discharge destination duration of RS therapy, ED length of stay (LOS), hospital LOS, the occurrence of adverse events, EWS score, triage score, ROX score) will be analysed using linear regression. Regression diagnostics will be utilised to test the adequacy and appropriateness of each model. If available, time to event data (for the requirement for escalation and mortality) will be analysed using a Cox proportional hazards model. The significance level will be set at p <0.05. In the regression models, the following variables will be assessed as predictors: participant age, ROX score at two hours post commencement of NHF, NHF flow rate, NHF FiO2, respiratory rate, triage score, EWS score, SpO2.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/12/2022
Actual
17/04/2023
Date of last participant enrolment
Anticipated
30/01/2023
Actual
15/05/2023
Date of last data collection
Anticipated
1/03/2023
Actual
13/06/2023
Sample size
Target
80
Accrual to date
Final
76
Recruitment outside Australia
Country [1] 23240 0
New Zealand
State/province [1] 23240 0
Auckland

Funding & Sponsors
Funding source category [1] 307331 0
University
Name [1] 307331 0
Health Research Council of New Zealand
Country [1] 307331 0
New Zealand
Primary sponsor type
University
Name
Health Research Council NZ
Address
PO Box 5541, Victoria Street West, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 307991 0
None
Name [1] 307991 0
Address [1] 307991 0
Country [1] 307991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307420 0
Massey University
Ethics committee address [1] 307420 0
Research Ethics, Graduate Research School
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Massey University
New Zealand
Ethics committee country [1] 307420 0
New Zealand
Date submitted for ethics approval [1] 307420 0
04/03/2022
Approval date [1] 307420 0
31/05/2022
Ethics approval number [1] 307420 0
NOR 22/18

Summary
Brief summary
The participant population is Adult Emergency Department (ED) patients who have a requirement for respiratory support.

The purpose of this study is to examine the nature of the respiratory support delivered in the ED. There shall be a specific focus on Nasal High Flow (NHF) therapy delivered to adults in the ED. This study shall explore the influence that this support has upon patient outcomes.

The overarching research questions are:

• What is the nature of the NHF delivered to adults in the ED setting?
• What influence does the delivery of NHF have upon adult ED patient outcomes?
The five specific research sub-questions are:

• Who receives NHF in the ED?
• How is NHF delivered in the ED?
• Which patients receiving NHF require escalation of therapy in the ED?
• What are the effects seen with NHF therapy on physiological and patient-centred outcomes?
Trial website
Trial related presentations / publications
Public notes
An HDEC representative granted a waiver of consent was granted due to the low-risk nature of the study.

Full ethical review is completed by Massey University and approval given

Contacts
Principal investigator
Name 107178 0
Mrs Jane ODonnell
Address 107178 0
The University of Auckland, Private Bag 92019,
Victoria St West, Auckland 1142, New Zealand
Country 107178 0
New Zealand
Phone 107178 0
+6421563836
Fax 107178 0
Email 107178 0
[email protected]
Contact person for public queries
Name 107179 0
Mrs Jane ODonnell
Address 107179 0
The University of Auckland, Private Bag 92019,
Victoria St West, Auckland 1142, New Zealand
Country 107179 0
New Zealand
Phone 107179 0
+6421563836
Fax 107179 0
Email 107179 0
[email protected]
Contact person for scientific queries
Name 107180 0
Mrs Jane ODonnell
Address 107180 0
The University of Auckland, Private Bag 92019,
Victoria St West, Auckland 1142, New Zealand
Country 107180 0
New Zealand
Phone 107180 0
+6421563836
Fax 107180 0
Email 107180 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
12069Study protocol  [email protected]



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.