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
ACTRN12617000301369
Ethics application status
Approved
Date submitted
23/02/2017
Date registered
27/02/2017
Date last updated
29/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Nasal high flow therapy in acute respiratory failure in Chronic Obstructive Pulmonary Disease – A feasibility study.
Scientific title
A feasibility study of Nasal High flow therapy in Acute Hypercapnic Respiratory Failure with Acidosis in patients presenting with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 291187 0
Nil
Universal Trial Number (UTN)
U1111-1185-3154
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 302078 0
Condition category
Condition code
Respiratory 301708 301708 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A standard of care protocol for Acute Exacerbation of COPD patients with Acute Hypercapnic Respiratory failure (AHRF) with acidosis will be agreed upon with Emergency Department staff. Patients presenting with an Acute Exacerbation of COPD will have an Arterial blood gas (ABG) as per current guidelines and venous blood gas (VBG) as per standard hospital practice.

Patients with a PaCO2 greater than 45mmHg and pH of greater than or equal to 7.25 and less than 7.35 will be enrolled into the observational study using a deferred consent model. A deferred consent model is required as people with COPD and acute hypercapnic respiratory failure have impaired capacity. All participants will receive standard medical therapy, including oxygen therapy titrated to oxygen saturations of 88-92%, bronchodilators and steroids as appropriate. After the 60 minute optimisation period participants will have a paired ABG and VBG and need for non-invasive ventilation will be assessed. Subsequent care will be determined by the treating physician.

During the 60 minute observational period the treatments received will be recorded to allow comparison of treatment received with the agreed standard care protocol. All participants will have their oxygen saturations and heart rate recorded by a pulse oximeter. This data will be downloaded after the 60 minute period completes.

As an observational study there is no intervention and all participants will receive standard medical care throughout. Participants will undergo one additional venous blood test that they would not normally require.

Deferred consent for the use of data will be obtained from patients once they are well enough to give informed consent. This will usually be within 48 hours of admission. If participants do not give consent their data will not be used in the study analysis.
Intervention code [1] 297189 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301106 0
The proportion of patients with treatment failure after 60 to 90 minutes. Treatment failure is defined as: death, need for Non-Invasive Ventilation or need for endotracheal intubation.
Timepoint [1] 301106 0
60-90 minutes. Note: Titrated oxygen therapy will be for 60 minutes, however the timepoint is extended up to 90 minutes to allow for delays between the initial ABG and final ABG.
Secondary outcome [1] 331732 0
Proportion of participants in whom care deviated from the agreed protocol of standard care. Data will be downloaded from a Masimo Rad-8 pulse oximeter device as well as reviewing clinical records.
Timepoint [1] 331732 0
60-90 minutes. Note: Titrated oxygen therapy will be for 60 minutes, however the timepoint is extended up to 90 minutes to allow for delays between the initial ABG and final ABG.
Secondary outcome [2] 331733 0
Proportion of patients admitted with an Acute Exacerbation of COPD (AECOPD) who meet the inclusion criteria as measured by a log of all AECOPD admission during the enrolment period.
Timepoint [2] 331733 0
Duration of time required to enrol 15 particpants, from March 2017.
Secondary outcome [3] 331734 0
Standard Deviation of the Hydrogen ion concentrations in the two arterial blood gases of eligible participants.
Timepoint [3] 331734 0
0 minutes and 60-90 minutes. Note: Titrated oxygen therapy will be for 60 minutes, however the timepoint is extended up to 90 minutes to allow for delays between the initial ABG and final ABG.
Secondary outcome [4] 331735 0
Proportion of participants in whom deferred consent could be obtained.
Timepoint [4] 331735 0
24-48 hours
Secondary outcome [5] 331736 0
Recruitment rates per month for each site.
Timepoint [5] 331736 0
Monthly

Eligibility
Key inclusion criteria
(1) Diagnosed with AECOPD causing AHRF with acidosis (pH of 7.25 - 7.34 on baseline Arterial Blood Gas)
(2) Age > 40 years of age
Minimum age
41 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patient requiring immediate NIV or intubation;
(2) Patients in whom NIV would never be considered clinically appropriate, e.g. advance care plan refusing NIV;
(3) Agitation sufficient to preclude study procedures;
(4) Specific contra-indications to NIV, e.g: Life-threatening hypoxaemia; Inability to protect airway; facial burns/trauma/recent facial or upper airway surgery; significant nasal/septal pathology; vomiting; fixed upper airway obstruction; undrained pneumothorax; copious respiratory secretions; haemodynamic instability requiring inotropes/vasopressors; pregnancy or breastfeeding.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Estimates of proportions will be by small sample technics e.g. Clopper-Pearson confidence intervals. The Standard Deviation for the Hydrogen ion concentration will have a confidence interval estimated using the Chi-square distribution. The proposed sample size of 40 for the Feasibility Study has 80% power, alpha 0.05, to rule out a baseline treatment failure rate of <60% assuming this is 80%. The sample size will also give reasonable precision for estimates of the SD of the Hydrogen ion concentration. Note: We will be completing an initial pilot of 15 patients at Wellington Hospital while we confirm funding for the proposed feasibility Study of sample size of 40.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8663 0
New Zealand
State/province [1] 8663 0
Wellington

Funding & Sponsors
Funding source category [1] 295630 0
Other
Name [1] 295630 0
Medical Research Institute of New Zealand
Address [1] 295630 0
Level 7, Clinical Services Building, Wellington Regional Hospital, Riddiford St, Newtown, Wellington 6021, New Zealand
Country [1] 295630 0
New Zealand
Primary sponsor type
Other
Name
Medical Research Institute of New Zealand
Address
Level 7, Clinical Services Building, Wellington Regional Hospital, Riddiford St, Newtown, Wellington 6021, New Zealand
Country
New Zealand
Secondary sponsor category [1] 294471 0
None
Name [1] 294471 0
Address [1] 294471 0
Country [1] 294471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296948 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 296948 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 296948 0
New Zealand
Date submitted for ethics approval [1] 296948 0
24/11/2016
Approval date [1] 296948 0
09/02/2017
Ethics approval number [1] 296948 0
16/NTA/227

Summary
Brief summary
This feasibility study aims to determine whether the planned full randomised controlled trial is feasible with the current design, timescale and number of sites. The feasibility study will not directly use the NHF device but instead test parts of the full study design. It comprises 2 parts:
Part 1: A usual care protocol for use of NIV in AECOPD with AHRF will be agreed upon between Wellington, Waikato and Christchurch Hospitals.
Part 2: Participants will be able to be enrolled in a deferred consent model according to the eligibility criteria in the full RCT and the protocol devised in Part 1 is able to be adhered to in 90%, but at least 75% of cases.
Patients presenting with an Acute Exacerbation of COPD will have an Arterial blood gas (ABG) and Venous blood gas (VBG) done as well as usual investigations. If Acute Hypercapnic Respiratory failure (AHRF) with acidosis, defined as PaCO2 greater than 45mmHg and pH of 7.25 - 7.34, is confirmed on ABG, standard medical treatment including Oxygen therapy titrated to oxygen saturations of 88-92% over 60 minutes will be implemented. We will use monitoring equipment with a downloadable function to assess compliance with the agreed standard of care. .A repeat ABG and VBG will be done after 60 minutes. Deferred consent for the use of information will be obtained from patients within 24-48 hours of admission.
We intend to run a pilot of 15 patients at Wellington Hospital only while we wait to hear about funding for the full 40 patient feasibility study. This will follow the same protocol as the feasibility study. If funding is secured the target sample size will be increased to 40.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72514 0
Dr James Fingleton
Address 72514 0
Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington Regional Hospital, Riddiford St, Newtown, Wellington 6021, New Zealand
Country 72514 0
New Zealand
Phone 72514 0
+64 4 8050247
Fax 72514 0
+64 4 3895707
Email 72514 0
james.fingleton@mrinz.ac.nz
Contact person for public queries
Name 72515 0
Dr James Fingleton
Address 72515 0
Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington Regional Hospital, Riddiford St, Newtown, Wellington 6021, New Zealand
Country 72515 0
New Zealand
Phone 72515 0
+64 4 8050247
Fax 72515 0
+64 4 3895707
Email 72515 0
james.fingleton@mrinz.ac.nz
Contact person for scientific queries
Name 72516 0
Dr James Fingleton
Address 72516 0
Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington Regional Hospital, Riddiford St, Newtown, Wellington 6021, New Zealand
Country 72516 0
New Zealand
Phone 72516 0
+64 4 8050247
Fax 72516 0
+64 4 3895707
Email 72516 0
james.fingleton@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary