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Trial registered on ANZCTR


Registration number
ACTRN12611001040954
Ethics application status
Approved
Date submitted
29/09/2011
Date registered
4/10/2011
Date last updated
25/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, parallel controlled trial on the effect of heated humidification on patient comfort and facial temperature in patients on non-invasive ventilation, using an oro-nasal facemask.
Scientific title
Effects of heated humidification during non-invasive ventilation on patient comfort with acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS).
Secondary ID [1] 273124 0
Nil
Universal Trial Number (UTN)
U1111-1124-8817
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 270875 0
Obesity Hypoventilation Syndrome (OHS) 270876 0
Condition category
Condition code
Respiratory 279053 279053 0 0
Chronic obstructive pulmonary disease
Respiratory 279054 279054 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Heated humidifier and heated respiratory circuit
A controlled, parallel study.
Patients already prescribed non-invasive ventilation (NIV) are randomised to 2 arms; humidified and non-humidified NIV. Patients are given up to 24 hours to stabilise on NIV, once they are stable on NIV they are asked if they want to take part in the study.
Patients in the humidified arm receive 4 hours of NIV, delivered from a standard hospital NIV ventilator, using the study heated humidifier, heated circuit and mask. The humidifier is turned off and does not contain any water as a washout, to establish a baseline. After 4 hours water is added to the heated humidifier and it is switched on and remains on for the following 8 hour treatment. In this intervention group the gas is heated and humidified to 31 degrees C, 32mg/L water.


Patients in the non-humidified arm receive 4 hours of NIV, delivered from a standard hospital NIV ventilator, using the study heated humidifier, heated circuit and mask. The humidifier is turned off and does not contain any water as a washout, to establish a baseline. The humidifier remains switched off with no water in it for the 12 hours of the study, 4 hour washout and 8 hours treatment.
Intervention code [1] 269466 0
Treatment: Devices
Comparator / control treatment
The placebo is 8 hours of non-invasive ventilation delivered by the same equipment but without adding water to it to provide humidity or turning the heater on.
Control group
Placebo

Outcomes
Primary outcome [1] 279707 0
Primary Outcome 1: Change in patient comfort score on a visual analogue scale of 1-10 after the treatment, compared to the baseline reading prior to the treatment.
Timepoint [1] 279707 0
Timepoint: At 8 hours of treatment
Secondary outcome [1] 294262 0
Secondary Outcome 1: Change in patient comfort score on a visual analogue scale of 1-10 during the treatment, compared to the baseline reading prior to the treatment.
Timepoint [1] 294262 0
Timepoint: At 4 hours of treatment.
Secondary outcome [2] 294263 0
Secondary Outcome 2: Change in NIV side effects, as determined by a patient questionnaire, compared to the baseline reading prior to the treatment.

Patients are asked on a 0-4 scale (0= not a problem, 1=slight problem, 2=moderate problem, 3= major problem, 4=NIV use suspended because of it).
The side effects assessed are: 1. pressure from mask or straps, 2. airleaks, 3. air pressure too high, 4. machine noise, 5. claustrophobia, 6. dry mouth or throat, 7. mouth or throat too hot, 8. runny nose, 9. congested nose, 10. nose bleeds, 11. head ache, 12. chest discomfort, 13. mask coming off face, 14. skin irritation under mask, 15. skin too hot under mask, 16. too hot generally.
Timepoint [2] 294263 0
Timepoint: At 4 hours and 8 hours of treatment.
Secondary outcome [3] 294264 0
Secondary Outcome 3: Number and timing of breaks from NIV over the 8 hours of treatment, and the reason.
Timepoint [3] 294264 0
Timepoint: Throughout the 8 hours of treatment
Secondary outcome [4] 294265 0
Secondary Outcome 4: Change in patient skin facial temperature on the cheek, outside of the mask, compared to the baseline reading prior to the treatment.
A temperature probe (thermocouple) will be temporarily taped to the patient's face using hypoallergenic tape and a reading taken, using a Fisher and Paykel Healthcare Thermister reader (TM101)
Timepoint [4] 294265 0
Timepoint: At 4 hours and 8 hours of treatment.
Secondary outcome [5] 294266 0
Secondary Outcome 5: Change in patient skin facial temperature on the chin, inside of the mask, compared to the baseline reading prior to the treatment.
A temperature probe (thermocouple) will be temporarily taped to the patient's face using hypoallergenic tape and a reading taken, using a Fisher and Paykel Healthcare Thermister reader (TM101)
Timepoint [5] 294266 0
Timepoint: At 4 hours and 8 hours of treatment.
Secondary outcome [6] 294267 0
Secondary Outcome 6: Change in patient core temperature, as determined by an ear thermometer, compared to the baseline reading prior to the treatment.
Timepoint [6] 294267 0
Timepoint: At 4 hours and 8 hours of treatment.

Eligibility
Key inclusion criteria
1. Acute ventilatory failure in patients with Chronic Obstructive Pulmonary Disease (COPD) or Obesity Hypoventilation Syndrome (OHS), or overlap syndrome (COPD and OHS)
2. NIV has been commenced on clinical grounds, in consultation with a Respiratory Physician
3. The patient has shown an initial positive clinical response to NIV
4. Patient has a good understanding of English
5. Patient is capable of giving informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. NIV is medically contraindicated
2. Delirium, dementia or confusion due to any cause
3. Patients considered as palliative
4. Kyphoscoliosis
5. Neuromuscular disease
6. Motor neuron disease
7. Cardiogenic pulmonary oedema
8. Unstable coronary disease
9. Facial deformity
10. Pneumothorax
11. NIV failure in the first hour (either intolerance or requirement for intubation)
12. Patient previously enrolled in the study

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)
Patients who fit the inclusion criteria and are stabilised on NIV within 24 hours of being in the respiratory ward are asked whether they would like to take part in the study. Allocation is according to a table of randomised treatments; Treatment A or Treatment B.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2011
Actual
22/08/2011
Date of last participant enrolment
Anticipated
Actual
20/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 3871 0
New Zealand
State/province [1] 3871 0
Auckland

Funding & Sponsors
Funding source category [1] 269946 0
Commercial sector/Industry
Name [1] 269946 0
Fisher and Paykel Healthcare
Country [1] 269946 0
New Zealand
Primary sponsor type
Hospital
Name
Counties Manukau District Health Board
Address
Middlemore Hospital,
Hospital Road,
Otahuhu,
Auckland,1640
Country
New Zealand
Secondary sponsor category [1] 268943 0
Individual
Name [1] 268943 0
Diana Hart
Address [1] 268943 0
Middlemore Hospital,
Hospital Road,
Otahuhu,
Auckland,1640
Country [1] 268943 0
New Zealand
Other collaborator category [1] 252269 0
Commercial sector/Industry
Name [1] 252269 0
Fisher and Paykel Healthcare
Address [1] 252269 0
15, Maurice Paykel Place,
East Tamaki,
Auckland 2013
Country [1] 252269 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271916 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 271916 0
Ethics committee country [1] 271916 0
New Zealand
Date submitted for ethics approval [1] 271916 0
28/06/2011
Approval date [1] 271916 0
18/07/2011
Ethics approval number [1] 271916 0
URA/11/07/028

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

Contacts
Principal investigator
Name 33210 0
Mrs Mrs Diana Hart
Address 33210 0
Third Floor, Support Building, Middlemore Hospital, Hospital Road, Otahuhu, Auckland, 1640
Country 33210 0
New Zealand
Phone 33210 0
+64 9 276 0044 ext 2036
Fax 33210 0
Email 33210 0
diana.hart@middlemore.co.nz
Contact person for public queries
Name 16457 0
Diana Hart
Address 16457 0
Third Floor, Support Building,
Middlemore Hospital,
Hospital Road,
Otahuhu,
Auckland, 1640
Country 16457 0
New Zealand
Phone 16457 0
+64 9 276 0044 ext 2036
Fax 16457 0
+64 9 276 0249
Email 16457 0
diana.hart@middlemore.co.nz
Contact person for scientific queries
Name 7385 0
Diana Hart
Address 7385 0
Third Floor, Support Building,
Middlemore Hospital,
Hospital Road,
Otahuhu,
Auckland, 1640
Country 7385 0
New Zealand
Phone 7385 0
+64 9 276 0044 ext 2036
Fax 7385 0
+64 9 276 0249
Email 7385 0
diana.hart@middlemore.co.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

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