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Trial registered on ANZCTR


Registration number
ACTRN12610000964011
Ethics application status
Approved
Date submitted
9/11/2010
Date registered
9/11/2010
Date last updated
17/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The HOTER Study: The Effect of Humidified High Flow Oxygen in the Emergency Room in Emergency Department Patients with Respiratory Distress
Scientific title
A study on the effect of humidified high flow oxygen therapy versus standard oxygen therapy on the need for assisted ventilation in emergency department patients with respiratory distress
Secondary ID [1] 280539 0
Nil
Universal Trial Number (UTN)
U1111-1117-8226
Trial acronym
HOTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute respiratory distress 258614 0
Condition category
Condition code
Respiratory 258758 258758 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nasal High Flow Oxygen is a technology whereby heated humidified oxygen is delivered via large bore nasal cannulae, enabling high flows of up to 50 L min-1 and a fraction of inspired oxygen (FiO2) which can be titrated from 21% to near 100%. These systems improve oxygenation through various mechanisms including washout of nasopharyngeal dead space, improved work of breathing through attenuation of inspiratory resistance, improved pulmonary compliance and provision of positive pressure. Heating and humidification of oxygen prevents mucosal dehydration, maintains ciliary activity, reduces heat loss and may minimise atelectasis and tracheitis.

Patients will be assessed for the presence of respiratory distress on arrival in the Emergency Department and if randomised to humidified high flow nasal Oxygen, receive 40L/min Oxygen for the duration of their Emergency Department stay. Once they leave the ED they will revert to standard Oxygen therapy at the discretion of the treating clinician
Intervention code [1] 257574 0
Treatment: Devices
Comparator / control treatment
Patients will be assessed for the presence of respiratory distress on arrival in the Emergency Department and if randomised to standard Oxygen therapy, receive Oxygen for the duration of their Emergency Department and hospital stays, at the discretion of the treating clinician. This may be standard nasal prong, Hudson mask or Venturi mask.
Control group
Active

Outcomes
Primary outcome [1] 259620 0
Need for Non-invasive or Invasive Ventilatory support Conversion to NIV or IPPV will be recorded as dichotomous data (yes/no). Descriptive statistics; proportions (95% CI), will be used to describe the measured parameters for each group. Categorical data will be analysed with Chi2 test or Fishers Exact Test as appropriate. All analysis will be intention-to-treat.
Timepoint [1] 259620 0
The point in time during the ED stay that the patient is commenced on NIV/IPPV will be measured. If this does not occur during the ED stay, the time of discharge or transfer out of the ED will be recorded.
Secondary outcome [1] 266267 0
Length of Hospital Stay (Days), defined as time of arrival in hospital to time of hospital discharge. This data is routinely recorded in an electronic database by clerical staff. The data is likely to be skewed to the right. Descriptive statistics; median (IQR) will be used to describe the measured parameters for each group. The primary outcome measure (and other non-parametric numerical data) will be analysed using the Mann Whitney U test. All analysis will be intention-to-treat.
Timepoint [1] 266267 0
The length of stay will be recorded (electronically time stamped) at the time of patient discharge and this time will be used for the analysis.
Secondary outcome [2] 266269 0
Mortality (yes/no). Descriptive statistics; proportions (95% CI), will be used to describe the measured parameters for each group. Categorical data will be analysed with Chi2 test or Fishers Exact Test as appropriate. All analysis will be intention-to-treat.
Timepoint [2] 266269 0
All outcomes other than length of stay will be measured during the patients time in ED and hospital, apart from mortality which will be assessed at 90 days from enrollment
Secondary outcome [3] 266270 0
Pneumothorax (yes/no), diagnosed on CxR. Descriptive statistics; proportions (95% CI), will be used to describe the measured parameters for each group. Categorical data will be analysed with Chi2 test or Fishers Exact Test as appropriate. All analysis will be intention-to-treat.
Timepoint [3] 266270 0
All outcomes other than length of stay will be measured during the patients time in ED and hospital, apart from mortality which will be assessed at 90 days from enrollment.
Secondary outcome [4] 266271 0
subcutaneous emphysema (yes/no) recorded in clincical notes or on xRay. Descriptive statistics; proportions (95% CI), will be used to describe the measured parameters for each group. Categorical data will be analysed with Chi2 test or Fishers Exact Test as appropriate. All analysis will be intention-to-treat.
Timepoint [4] 266271 0
All outcomes other than length of stay will be measured during the patients time in ED and hospital, apart from mortality which will be assessed at 90 days from enrollment
Secondary outcome [5] 266272 0
Patient Satisfaction with treatment will be recorded on a 6 item, 5 point Likert scale questionnaire. There will be space for additional comments. Descriptive statistics; proportions (95% CI), will be used to describe the measured parameters for each group. Categorical data will be analysed with Chi2 test. All analysis will be intention-to-treat.
Timepoint [5] 266272 0
The questionnaire will be administered as soon as possible after completion of Emergency Department treatment.
Secondary outcome [6] 266273 0
Unexpected Adverse Events recorded in clincical notes or reported by the patient. These will be described in the text fo the report and with descriptive statistics; proportions (95% CI), will be used to describe the measured parameters for each group. Categorical data will be analysed with Chi2 test or Fishers Exact Test as appropriate. All analysis will be intention-to-treat.
Timepoint [6] 266273 0
All outcomes other than length of stay will be measured during the patients time in ED and hospital, apart from mortality which will be assessed at 90 days from enrollment

Eligibility
Key inclusion criteria
1. Adult patient (15 years or older) presenting to the Auckland City Hospital Emergency Department (AED).
2. Oxygenation impairment or respiratory distress as a presenting feature (defined as transcutaneous oxygen saturations measured at less than or equal to 92% on air (or less than or equal to 90% in the setting of chronic hypercapnia) AND respiratory rate greater than or equal to 22 breaths per minute at any time enroute to hospital or on arrival).
3. Oxygen therapy indicated in the opinion of the treating clinician.
Minimum age
15 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intubated / NIPPV on arrival to or immediately in AED
Bullous lung disease
Pneumothorax
Anatomical abnormality or malformation of the face
Suspected facial or intracranial trauma
Recent episode of epistaxis (less than 2 weeks)
Recent facial surgery (less than 6 weeks)
Prior history of trans-nasal neurosurgery
Prior decision that the patient is for palliative care only

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)
Allocation will be done by study personnel using a locally-developed, purpose-built computer randomisation program in Microsoft Access 2003TM, based on a random number generator. Allocation is not concealed, however the number of patients allocated to each group will be cross referenced with the schedule generated by the randomisation program to check for bias in allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be recruited and randomised on arrival to AED using a locally-developed, purpose-built computer randomisation program in Microsoft Access 2003TM, based on a random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
For those patients that are unable to give written informed consent at the time of enrollment due to the severity of their illness, a process of delayed consent will be used (approval for this will be sought from the regional ethics committee prior to commencement of the study)
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/07/2012
Actual
6/07/2012
Date of last participant enrolment
Anticipated
Actual
5/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 3027 0
New Zealand
State/province [1] 3027 0
Auckland

Funding & Sponsors
Funding source category [1] 258029 0
Charities/Societies/Foundations
Name [1] 258029 0
Green Lane Research and Education Fund
Country [1] 258029 0
New Zealand
Primary sponsor type
Individual
Name
Dr Peter Jones
Address
Mail:
c/- Adult Emergency Department
Auckland City Hospital
Private Bag 92024
Victoria St West
Auckland 1142
New Zealand

Physical:
Adult Emergency Department
Auckland City Hospital
Park Road
Grafton
Auckland
Country
New Zealand
Secondary sponsor category [1] 257221 0
None
Name [1] 257221 0
Address [1] 257221 0
Country [1] 257221 0
Other collaborator category [1] 251647 0
Individual
Name [1] 251647 0
Dr Sinan Kamona
Address [1] 251647 0
Mail:
c/- Adult Emergency Department
Auckland City Hospital
Private Bag 92024
Victoria St West
Auckland 1142
New Zealand

Physical:
Adult Emergency Department
Auckland City Hospital
Park Road
Grafton
Auckland
Country [1] 251647 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260024 0
Northern X Regional Ethics Committee
Ethics committee address [1] 260024 0
Ethics committee country [1] 260024 0
New Zealand
Date submitted for ethics approval [1] 260024 0
16/11/2010
Approval date [1] 260024 0
03/04/2012
Ethics approval number [1] 260024 0
NTX/10/12/121

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

Contacts
Principal investigator
Name 31890 0
Dr Peter Jones
Address 31890 0
Department of Adult Emergency Medicine Auckland City Hospital Private Bag 92042 Victoria St West Auckland 1142
Country 31890 0
New Zealand
Phone 31890 0
+64 9 307 4949
Fax 31890 0
Email 31890 0
peterj@adhb.govt.nz
Contact person for public queries
Name 15137 0
Dr Peter Jones
Address 15137 0
Department of Adult Emergency Medicine
Auckland City Hospital
Private Bag 92042
Victoria St West
Auckland 1142
Country 15137 0
New Zealand
Phone 15137 0
+6493074949
Fax 15137 0
Email 15137 0
peterj@adhb.govt.nz
Contact person for scientific queries
Name 6065 0
Dr Peter Jones
Address 6065 0
Department of Adult Emergency Medicine
Auckland City Hospital
Private Bag 92042
Victoria St West
Auckland 1142
Country 6065 0
New Zealand
Phone 6065 0
+6493074949
Fax 6065 0
Email 6065 0
peterj@adhb.govt.nz

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.