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Trial registered on ANZCTR


Registration number
ACTRN12608000175370
Ethics application status
Approved
Date submitted
2/04/2008
Date registered
9/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study Into Noninvasive Ventilation and it's Impact on Lung Pressures at Different Ventilator Settings
Scientific title
A Study of Cardiac Surgical Patients Using Noninvasive Ventilation and it's impact on Mean Nasopharyngeal Airway Pressure at Different Pressure Settings
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Repiratory Failure 2989 0
Condition category
Condition code
Respiratory 3139 3139 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whilst participants (n=12) are still sedated following cardiac surgery, a 10F pressure catheter will be inserted into the nasopharynx via the nose. Once awake and extubated, participants will be commenced on face mask noninvasive ventilation. Once settled on the therapy the pressure catheter position will be confirmed using end tidal CO2 monitoring. Pressure measurements will then be carried out at three different pressure settings: 3, 5 and 7 cmH20 with mouth open and then repeated mouth closed. Simultaneously, pressure in the face mask will recorded using a separate pressure catheter attached to a pressure monitoring port on the mask. The pressure catheter in the nasopharynx will be gently removed at the end of the study period. The measurements will take approximately 30mins to complete. The intervention is noninvasive ventilation at three different pressure settings. We are investigating the relationship between the pressure in the face mask and the pressure in the nasopharynx. We hypothesise that there is a difference between mask pressure and nasopharyngeal pressure and that this difference varies between patients.
Intervention code [1] 2729 0
Treatment: Devices
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4023 0
Mean airway pressure as determined by measurements taken over one minute of breathing. Specially designed software will be used to carry out the measurements and calculate the means
Timepoint [1] 4023 0
Measurement is continuous over one minute. Mean is calculated by averaging the peak and trough pressures over the entire minute of breathing.
Secondary outcome [1] 6777 0
Mean face mask pressures as determined by measurements taken over one minute of breathing. Specially designed software will be used to carry out the measurements and calculate the means
Timepoint [1] 6777 0
Measurement is continuous over one minute. Mean is calculated by averaging the peak and trough pressures over the entire minute of breathing.

Eligibility
Key inclusion criteria
Patients are eligible for inclusion if all of the following criteria are met:
Consent has been obtained; The patient is 18 years or older; Consent has been obtained; The patient is undergoing cardiac surgery requiring sternotomy
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if one or more of the following criteria are present: The patient has significant nasal septum deviation; Non-invasive ventilation is contraindicated; Following surgery the patient is unable to follow simple commands once awake and extubated

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a descriptive study and is therefore not randomised or blinded
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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] 855 0
New Zealand
State/province [1] 855 0

Funding & Sponsors
Funding source category [1] 3252 0
Commercial sector/Industry
Name [1] 3252 0
Fisher and Paykel Healthcare
Address [1] 3252 0
15 Maurice Paykel Place
East Tamaki
Auckland
Country [1] 3252 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland
Country
New Zealand
Secondary sponsor category [1] 2907 0
Government body
Name [1] 2907 0
Auckland District Health Board
Address [1] 2907 0
Cardiothoracic and Vascular Intensive Care Unit. Level 4. Auckland City Hospital. Park Road. Grafton. Auckland.
Country [1] 2907 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5236 0
Northern X New Zealand ethics committee
Ethics committee address [1] 5236 0
Ethics committee country [1] 5236 0
New Zealand
Date submitted for ethics approval [1] 5236 0
Approval date [1] 5236 0
Ethics approval number [1] 5236 0

Summary
Brief summary
The primary purpose of this study is to investigate whether the pressure generated in the airway of a patient receiving noninvasive ventilation with a sealed face mask (used to assist breathing during respiratory failure / distress) is the same as the pressure generated in the mask. There is an assumption that the pressure in the mask is similar to the pressure in the airway. We think that it is likely to be lower in the airway due to resistance in the nose but the degree of difference will vary between individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28485 0
Address 28485 0
Country 28485 0
Phone 28485 0
Fax 28485 0
Email 28485 0
Contact person for public queries
Name 11642 0
Rachael Parke
Address 11642 0
Cardiothoracic and Vascular Intensive Care Unit. Level 4. Auckland City Hospital. Park Road. Grafton. Auckland.
Country 11642 0
New Zealand
Phone 11642 0
+64 9 3074949 ext 24489
Fax 11642 0
Email 11642 0
rparke@adhb.govt.nz
Contact person for scientific queries
Name 2570 0
Michelle Eccleston
Address 2570 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland
Country 2570 0
New Zealand
Phone 2570 0
+64 9 5740123 ext 8671
Fax 2570 0
Email 2570 0
michelle.eccleston@fphcare.co.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