Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000180213p
Ethics application status
Submitted, not yet approved
Date submitted
23/01/2018
Date registered
5/02/2018
Date last updated
5/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The safety and effectiveness of nasal high flow oxygen therapy to improve ward patients' pulmonary function.
Scientific title
The safety and effectiveness of nasal high flow oxygen therapy in the adult ward patient: a prospective observational multi-centre study
Secondary ID [1] 293855 0
None
Universal Trial Number (UTN)
U-1111-1208-3410
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory failure 306316 0
Pulmonary dysfunction 306317 0
Condition category
Condition code
Respiratory 305396 305396 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Days
Description of intervention(s) / exposure
Nasal high flow (NHF) oxygen therapy will be delivered via the Optiflow™ system (Fisher and Paykel Healthcare, NZ Ltd) using the AIRVO™ 2 (Fisher and Paykel Healthcare, NZ Ltd) to adult ward patients. Data on patients' pulmonary function will be collected immediately prior to commencing nasal high flow oxygen and until the therapy is discontinued or up to 72 hours after the intervention was commenced. Patients will receive NHF oxygen therapy as determined by the Patient at Risk team or ICU outreach nurse. Oxygen and Airvo 2 flow rate (FiO2) and Airvo 2 temperature will be altered by the Patient at Risk team or ICU outreach nurse in response to respiratory rate, oxygen saturations, work of breathing and comfort.
Intervention code [1] 300113 0
Not applicable
Comparator / control treatment
No control group will be used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304537 0
Change in pulmonary function as calculated using respiratory and heart rates and oxygen saturation via pulse oximetry (SpO2).
Timepoint [1] 304537 0
Outcome collected within 1 hour after commencing NHF flow oxygen
Secondary outcome [1] 342296 0
Change in dyspnoea as calculated by a 5-point Likert Scale- marked deterioration, slight deterioration, no change, slight improvement, marked improvement.
Timepoint [1] 342296 0
Outcome collected until the intervention is discontinued or until a maximum of 72 hours post commencement of intervention
Secondary outcome [2] 342603 0
Change in sputum clearance as assessed by the patient &/or Patient at Risk team or ICU outreach nurse and calculated using a dichotomous score improved/not improved
Timepoint [2] 342603 0
Outcome collected until the intervention is discontinued or until a maximum of 72 hours post commencement of the intervention.
Secondary outcome [3] 342604 0
Patient outcome as calculated by 30 day mortality
Timepoint [3] 342604 0
Outcome collected 30 days post intervention.
Secondary outcome [4] 342605 0
A deterioration in patients' pulmonary function as indicated by the number of patients admitted to ICU.
Timepoint [4] 342605 0
Outcome collected up to 72 hours after intervention commenced

Eligibility
Key inclusion criteria
1. All patients in a hospital where NHF oxygen therapy is already being used in adult ward patients.
2. All ward patients greater than 18 years of age with clinical signs of ongoing hypoxaemia associated with an acute or acute on chronic condition and receiving oxygen delivered via low flow nasal prongs or mask
OR
3. All ward patients greater than 18 years of age who are at risk of respiratory deterioration as per clinician’s assessment
AND
4. Have NHF oxygen therapy delivered via the Optiflow™ system (Fisher and Paykel Healthcare, NZ Ltd) using the AIRVO™ 2 (Fisher and Paykel Healthcare, NZ Ltd)
AND
5. In a hospital that utilises an early warning score to identify patient deterioration
AND
6. In a hospital that has an intensive care outreach nurse/team and/or Patient at Risk team involved in their care.
AND
7. Has ability to provide informed consent in their well state.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving end of life care, facial trauma/surgery patients, patients with conditions that contraindicate the application of continuous positive airway pressure (CPAP), patients who are using NHF oxygen therapy intermittently with Bi-level ventilation, patients who are receiving NHF oxygen therapy via a mask rather than nasal cannula, patients who are continuing NHF oxygen therapy in the ward after discharge from critical care or the emergency department, and patients in non-ward areas such as emergency care and critical care.


Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
De-identified data will be entered into Survey Monkey for ease of data entry by research assistants. Survey Monkey data will be exported to the Statistical Programme for Social Sciences (SPSS) version 23 for descriptive and statistical analysis. The mean and Standard Deviation will describe normally distributed data and the median and interquartile range will describe skewed data.

The two-tailed independent t-test, Mann Whitney U test, chi-square test, and Fisher’s Exact Probability test will compare hospital and subgroup patient characteristics. The parametric repeated measures t-test will analyse normally distributed primary outcome data. The parametric one-way repeated measures analysis of variance will analyse normally distributed continuous primary and secondary outcome data collected over a two-day period. The McNemar’s test will analyse secondary outcome categorical variables. The alpha level for statistical significance will be set at 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2018
Actual
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
1/09/2019
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 9516 0
New Zealand
State/province [1] 9516 0

Funding & Sponsors
Funding source category [1] 298476 0
University
Name [1] 298476 0
Massey University Research Fund
Country [1] 298476 0
New Zealand
Primary sponsor type
Individual
Name
Alison Pirret
Address
School of Nursing
Massey University Albany
Private Bag 102094
Northshore
Auckland 0745
New Zealand
Country
New Zealand
Secondary sponsor category [1] 297613 0
Individual
Name [1] 297613 0
Susan Takerei
Address [1] 297613 0
Patient at Risk Team
Critical Care Complex
Middlemore Hospital
Private Bag 93311
100 Hospital Rd
Otahuhu
Auckland 2025
Country [1] 297613 0
New Zealand
Secondary sponsor category [2] 297614 0
Individual
Name [2] 297614 0
Claire Minton
Address [2] 297614 0
School of Nursing
Massey University Manawatu
Private Bag 11 222
Palmerston North 4442
Country [2] 297614 0
New Zealand
Secondary sponsor category [3] 297616 0
Individual
Name [3] 297616 0
Jennfier Hill
Address [3] 297616 0
Deteriorating Patient Programme
Health Quality & Safety Commission
PO Box 25496
Wellington 6146
Country [3] 297616 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299462 0
Health & Disability Ethics Commitee
Ethics committee address [1] 299462 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 299462 0
New Zealand
Date submitted for ethics approval [1] 299462 0
23/01/2018
Approval date [1] 299462 0
Ethics approval number [1] 299462 0

Summary
Brief summary
This study will determine the safety and effectiveness of nasal high flow therapy to improve the respiratory function of adult ward patients in hospitals in New Zealand. The primary outcome will be an improvement in respiratory function as indicated by reductions in respiratory and heart rates and improvement in blood oxygen as measured via the pulse oximeter (SpO2) within an hour of commencing nasal high flow oxygen therapy. Secondary outcomes include improved difficulty in breathing and phlegm clearance and no evidence of delays in escalating to higher levels of care, such as an intensive care unit, within an hour of commencing nasal high flow oxygen therapy and over the next 72 hours. .
The study will recruit a minimum of 300 adult ward patient (150 medical and 150 surgical) receiving nasal high flow oxygen therapy in New Zealand hospitals where the use of nasal high flow oxygen therapy in the ward setting is an established practice.

Data will be collected using a data collection sheets consisting of 2 parts: 1) hospital demographics and 2) patient data. Data related to blood results, length of stay and discharge outcome will be collected from the patients’ electronic records by site coordinators. Patient data will be de-identified prior to entering the data into a Survey
Monkey data base and exporting to a statistical software package for analysis.
Trial website
Trial related presentations / publications
Public notes
A single site study (Pirret et al. 2015) identified NHF oxygen therapy was a safe and effective therapy in the adult ward patient. However as this was a single site study the results cannot be generalised to ward patients in other hospitals.
Attachments [1] 2391 2391 0 0
/AnzctrAttachments/374357-HDEC participant information sheet.doc (Participant information/consent)
Attachments [2] 2403 2403 0 0
/AnzctrAttachments/374357(v31-01-2018-09-32-08)-NHF multicentre study January 18.doc (Protocol)

Contacts
Principal investigator
Name 80486 0
Dr Alison PIrret
Address 80486 0
Critical Care Complex
Middlemore Hospital
Private Bag 93311
100 Hospital Road
Otahuhu
Auckland 2025
Country 80486 0
New Zealand
Phone 80486 0
+6421508312
Fax 80486 0
+6492760112
Email 80486 0
[email protected]
Contact person for public queries
Name 80487 0
Alison Pirret
Address 80487 0
School of Nursing
Massey University
Private Bag 102904
Northshore
Auckland 0745
Country 80487 0
New Zealand
Phone 80487 0
+6494140800
Fax 80487 0
Email 80487 0
[email protected]
Contact person for scientific queries
Name 80488 0
Alison Pirret
Address 80488 0
School of Nursing
Massey University
Private Bag 102904
Northshore
Auckland 0745
Country 80488 0
New Zealand
Phone 80488 0
+6494140800
Fax 80488 0
Email 80488 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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