Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001180505
Ethics application status
Approved
Date submitted
19/10/2015
Date registered
3/11/2015
Date last updated
26/04/2022
Date data sharing statement initially provided
17/04/2019
Date results provided
26/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Positive Airway Pressure (CPAP) for the treatment of severe respiratory distress in the pre-hospital setting
Scientific title
Continuous Positive Airway Pressure (CPAP) trial for the treatment of severe respiratory distress by ambulance paramedics in the pre-hospital setting.
Secondary ID [1] 287695 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe respiratory distress. 296528 0
Heart failure 296529 0
Condition category
Condition code
Respiratory 296790 296790 0 0
Other respiratory disorders / diseases
Cardiovascular 296791 296791 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous Positive Airway Pressure (CPAP) and usual care.
CPAP will be delivered continuously by a CPAP facial mask, set at 10cm H2o by ambulance paramedics.
CPAP will be delivered by the paramedic from identification of severe respiratory distress until arrival at the hospital.
Usual care is the care routinely administered by paramedics for severe respiratory distress that is guided by the ambulance Clinical Practice Guidelines.
Intervention code [1] 293089 0
Treatment: Devices
Comparator / control treatment
Usual care is the care routinely administered by paramedics for severe respiratory distress that is guided by the ambulance Clinical Practice Guidelines. This consists of oxygen delivered by mask or bag ventilation, vasodilators if the patient is in acute pulmonary oedema, and bronchodilators if the patient has a wheeze.
Control group
Active

Outcomes
Primary outcome [1] 296394 0
Changes in respiratory rate assessed by paramedics, as indicated on electronic patient care record (e-PCR)
Timepoint [1] 296394 0
Paramedic arrival within 5 minutes at the prehospital scene to immediately prior to arrival to the emergency department
Primary outcome [2] 296432 0
Changes in the VAS dyspnoea score measured by a Visual Analogue Scale that patients rate their difficulty in breathing from 1 (no shortness of breath) to 10 (worst difficulty in breathing imaginable)
Timepoint [2] 296432 0
Paramedic arrival within 5 minutes at the prehospital scene to immediately prior to arrival to the emergency department
Primary outcome [3] 319798 0
Duration of hospital length of stay (LOS) (days) - as determined by hospital records
Timepoint [3] 319798 0
Length of stay will be calculated in days. after discharge from hospital
Secondary outcome [1] 318334 0
Changes in peripheral oxygen saturation (SpO2) using pulse oximetry and recorded on electronic patient care record by paramedics that is uploaded to ambulance server
Timepoint [1] 318334 0
From paramedic arrival within 5 minutes at the prehospital scene to immediately prior to arrival to the emergency department.
Secondary outcome [2] 318432 0
Time from paramedics arrival on scene to arrival at the hospital (in minutes) - data obtained from ambulance Computer Aided Dispatch data that is uploaded to ambulance server
Timepoint [2] 318432 0
Minutes from time of arrival at scene to time of hospital arrival from Computer Aided Dispatch data that is uploaded to ambulance server
Secondary outcome [3] 318433 0
Occurrence of intubations.
Pre-hospital data will be collected from the Ambulance Service electronic patient care record, in-hospital data will be collected from the medical record.
Timepoint [3] 318433 0
ED discharge; data from emergency department informations system linked to ambulance services database
Secondary outcome [4] 318434 0
Proportion of ICU admissions.
ICU admission and discharge time and date will be collected from the hospital medical record.
Timepoint [4] 318434 0
Hospital discharge
Secondary outcome [5] 318435 0
Duration of hospital LOS (days); data from medical record review linked to ambulance services database
Timepoint [5] 318435 0
Hospital discharge
Secondary outcome [6] 318436 0
Survival to hospital discharge.
Survival outcome will be obtained from the hospital medical record.
Timepoint [6] 318436 0
Hospital discharge
Secondary outcome [7] 318437 0
Duration of CPAP and oxygen therapy recorded by paramedics on electronic patient care record that is uploaded to ambulance server
Timepoint [7] 318437 0
ED discharge
Secondary outcome [8] 318438 0
Duration of ED continuation of CPAP for at least 30 minutes assessed by review of hospital records;
Timepoint [8] 318438 0
Hospital discharge
Secondary outcome [9] 318439 0
Proportion of clinical complications, e.g. unplanned intubation, cardiac arrest; adverse events, e.g. barotrauma all assessed from review of hospital records;
Timepoint [9] 318439 0
Continuous monitoring from start of CPAP to one hour post end of CPAP
Secondary outcome [10] 369570 0
30-day survival
Timepoint [10] 369570 0
30 days after initial event

Eligibility
Key inclusion criteria
Age 40 plus years, transported to a metropolitan hospital by ambulance, respiratory rate > 22 breaths per minute and identified by paramedics as experiencing severe respiratory distress of non-traumatic origin which is deteriorating despite 5 minutes of appropriate therapy
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded if immediate endotracheal intubation or other methods of airway control, e.g. laryngeal mask airway are required; unconscious or only responds to pain; systolic blood pressure <90mmHg; uncooperative patient; possible pneumothorax, anaphylaxis, drowning, smoke inhalation, or aspiration

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)
Group allocation will be placed in externally numbered, sealed opaque tamper-evident envelopes. Research paramedics will be provided with a set of randomisation envelopes. As each is used, it will be replaced at the earliest convenient time from the remaining envelopes held at the ambulance station
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation will be used to create a randomisation schedule. Block randomisation will be used, with a random block size, to ensure relative balance of the numbers in each group at any time
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis
All analyses will be performed on an intention-to-treat basis. For missing data, the number of available observations will be reported. No assumptions will be made about the missing data. Baseline cohort characteristics such as age, sex, presenting problem will be compared between treatment groups using chi-square tests for categorical variables and independent sample t-tests (or the non-parametric equivalents) for continuous variables. The tests will be two-sided and considered statistically significant if p<0.01. The primary outcomes and secondary outcomes that are continuous variables will firstly be compared between study groups using either parametric (ttest) or non-parametric (Mann-Whitney) statistics, depending on the underlying assumptions of the test being met.

Regression techniques will be used to model the effect of the treatment group (CPAP and usual care compared to usual care), with adjustment for potential confounders. Previous studies have not shown delay at the scene as a result of administering CPAP. Patients will usually be in the ambulance when CPAP is commenced. Nevertheless we will collect these data and adjust for pre-hospital time intervals in multivariable analyses if required. An ‘a priori’ subgroup analysis of patients with APO, COPD and pneumonia will also be conducted. All statistical analyses will be undertaken under the direction of the nominated biostatistician and will include the use of SPSS, and STATA statistical software.

Sample size and power
Calculations are based on 90% power and an alpha level of 0.05 (PS Power and Sample Size
Calculations, V 3.0, Jan 2009):
Respiratory rate: The mean decrease in respiratory rate under standard care of 4.1 breaths per
minute (13%) (SD 5.8 breaths per minute) was determined from 1729 SJA-WA cases transported
between 20.09.2012 and 19.09.2013 with APO (15% of cases), COPD (36%) or respiratory tract
infections (49%). Assuming the SD of 10.4 observed in the pilot study, if there is an additional 20%
difference in the respiratory rate in the experimental group, we need to study 60 patients in each
group to be able to reject the null hypothesis that the population means of the experimental and
control groups are equal.
Dyspnoea score: Based on prehospital data, the decrease in dyspnoea under standard care is
approximately 1 unit (SD 3.1). Assuming the same SD, and an additional 2 unit difference in the
experimental group, we need to study 25 patients in each group to be able to reject the null
hypothesis that the population means of the experimental and control groups are equal.
To ensure sufficient power to enable sub-group multivariable analyses and assuming a minimum
prevalence of 16% (1/6) in each subgroup: (1) patients with respiratory rates >=25; (2)
APO; (3) COPD; (4) respiratory tract infections; we plan to recruit 360 patients per group (for 1/6
prevalence we require 6 x 60 patients per group), i.e. 720 in total.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2015
Actual
3/03/2016
Date of last participant enrolment
Anticipated
26/11/2017
Actual
31/12/2018
Date of last data collection
Anticipated
31/05/2019
Actual
30/06/2019
Sample size
Target
720
Accrual to date
Final
708
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 292248 0
Government body
Name [1] 292248 0
WA Department of Health SHRAC Research Translation Project funding (R10)
Country [1] 292248 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street Bentley Western Australia 6102
Country
Australia
Secondary sponsor category [1] 290925 0
None
Name [1] 290925 0
Nil
Address [1] 290925 0
Nil
Country [1] 290925 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293712 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 293712 0
Ethics committee country [1] 293712 0
Australia
Date submitted for ethics approval [1] 293712 0
26/08/2015
Approval date [1] 293712 0
03/12/2015
Ethics approval number [1] 293712 0
HR220/2015
Ethics committee name [2] 303182 0
Sir Charles Gairdner and Osborne Park Health Care Group (SCGOPHCG) Human Research Ethics Committee (HREC)
Ethics committee address [2] 303182 0
Ethics committee country [2] 303182 0
Australia
Date submitted for ethics approval [2] 303182 0
Approval date [2] 303182 0
16/03/2017
Ethics approval number [2] 303182 0
2016-148

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61062 0
Prof Judith Finn
Address 61062 0
Prehospital Resuscitation and Emergency Care Research Unit, School of Nursing, Midwifery and Paramedicine, Curtin University, GPO Box U1987, Perth, Western Australia 6845
Country 61062 0
Australia
Phone 61062 0
+61 8 9266 4447
Fax 61062 0
Email 61062 0
[email protected]
Contact person for public queries
Name 61063 0
Judith Finn
Address 61063 0
Prehospital Resuscitation and Emergency Care Research Unit, School of Nursing, Midwifery and Paramedicine, Curtin University, GPO Box U1987, Perth Western Australia 6845
Country 61063 0
Australia
Phone 61063 0
+61 8 9266 4447
Fax 61063 0
Email 61063 0
[email protected]
Contact person for scientific queries
Name 61064 0
Judith Finn
Address 61064 0
Prehospital Resuscitation and Emergency Care Research Unit, School of Nursing, Midwifery and Paramedicine, Curtin University, GPO Box U1987, Perth Western Australia 6845
Country 61064 0
Australia
Phone 61064 0
+61 8 9266 4447
Fax 61064 0
Email 61064 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
Confidential patient care records


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4228Ethical approval  [email protected]
4229Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePrehospital continuous positive airway pressure (CPAP) for acute respiratory distress: A randomised controlled trial.2022https://dx.doi.org/10.1136/emermed-2020-210256
N.B. These documents automatically identified may not have been verified by the study sponsor.