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
ACTRN12609000037202
Ethics application status
Approved
Date submitted
1/12/2008
Date registered
19/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the generation of respiratory pressure by high flow nasal prongs using pressure measuring and lung imaging techniques
Scientific title
An investigation of cardiac surgical patients receiving nasal high flow therapy using a pressure measuring transducer and electrical impedence tomography to assess nasopharyngeal pressure and functional residual capacity
Secondary ID [1] 253075 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress / failure, post operative recovery from cardiac surgery 4047 0
Condition category
Condition code
Respiratory 4251 4251 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following cardiac surgery, patients who are already receiving Nasal High Flow (NHF) as part of their usual care will be approached to participate in this study (NHF = blended air and oxygen which has been warmed and humidified and delivered via nasal cannula at flows of up to 50L/min. Patients may receive this therapy for a few hours or a few days depending on their clinical condition).
The research procedure is as follows:
1 Informed consent
2 Insert pressure measuring catheter into the patient’s nasopharynx.
3 Attach belt of electrodes around patient’s chest.
4 Change from NHF to face mask oxygen therapy
5 10 -15 min wash out period
6 Arterial blood gas taken if Arterial line is in situ
7 Simultaneous pressure measurements and electrical readings recorded for a 2 min period.
8 Change from face mask oxygen therapy to NHF
9 10 - 15 min wash out period
10 Arterial blood gas taken if arterial line is in situ
11 Simultaneous pressure measurements and electrical readings recorded for a 2 min period
12 Remove pressure measuring catheter
13 Remove belt of electrodes
14 Continue with usual care
Patients will receive the same concentration of oxygen with either therapy and this will be dictated by the patient’s clinical requirements. Physiological and demographic data from the patient’s medical chart will also be recorded.
Intervention code [1] 3861 0
Treatment: Devices
Comparator / control treatment
The control treatment will be face mask oxygen therapy
Control group
Active

Outcomes
Primary outcome [1] 5136 0
Functional residual capacity measured by electrical impedance tomography
Timepoint [1] 5136 0
Electrical impedence tomography to assess functional residual capacity will be carried out during the study period. Approximately 2 minutes of continuous recording per flow rate and mouth position. The whole study period is approximately 30 minutes after which no further outcomes are assessed
Secondary outcome [1] 8645 0
Nasopharyngeal pressure. Measured via a size 8 French nasogastric tube inserted into the nasopharynx and connected to a pressure transducer. The pressure transducer connects to a laptop computer where recordings are downloaded.
Timepoint [1] 8645 0
Nasopharyngeal pressure measuring will be carried out during the study period. Approximately 2 minutes of continuous recording per flow rate and mouth position. The whole study period is approximately 30 minutes after which no further outcomes are assessed

Eligibility
Key inclusion criteria
Patients following cardiac surgery requiring treatment with nasal high flow therapy
Minimum age
18 Years
Maximum age
95 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Air leak syndrome
Patient requiring electrical pacing via temporary pacing wires
Patient with an open sternum
Patient requiring noninvasive ventilation who cannot tolerate being off this for 15 minutes or greater

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4225 0
Commercial sector/Industry
Name [1] 4225 0
Fisher and Paykel Healthcare
Address [1] 4225 0
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country [1] 4225 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 3801 0
Hospital
Name [1] 3801 0
Prince Charles Hospital
Address [1] 3801 0
Rode Road
Brisbane
Queensland 4012
Country [1] 3801 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6280 0
Human Research Ethics Committee, Prince Charles Hospital
Ethics committee address [1] 6280 0
Northside Health Service District
Rode Road
Brisbane
Queensland 4032
Ethics committee country [1] 6280 0
Australia
Date submitted for ethics approval [1] 6280 0
Approval date [1] 6280 0
17/04/2008
Ethics approval number [1] 6280 0
EC27105

Summary
Brief summary
After cardiac surgery the lungs may suffer from a small amount of collapse and may require extra assistance to re-expand. If this occurs nasal high flow therapy may be applied (delivery of warmed and humidified medical gas via the nose at flow rates up to 50 L/min). It is believed that this flow generates a degree of positive pressure in the lungs which is beneficial to patients with some degree of lung collapse. Assessment of the physiological effect by two different methods (pressure measurement in the upper airway and by a lung imaging technique called electrical impedence tomography) will help doctors understand the effects of this therapy better and will form the basis for future research in this area.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29182 0
Address 29182 0
Country 29182 0
Phone 29182 0
Fax 29182 0
Email 29182 0
Contact person for public queries
Name 12339 0
Amanda Corely
Address 12339 0
ICU
Prince Charles Hospital
Rode Road
Brisbane
Queensland 4012
Country 12339 0
Australia
Phone 12339 0
+61731395772
Fax 12339 0
Email 12339 0
amanda_corley@health.qld.gov.au
Contact person for scientific queries
Name 3267 0
Dr John Fraser
Address 3267 0
ICU
Prince Charles Hospital
Rode Road
Brisbane
Queensland 4012
Country 3267 0
Australia
Phone 3267 0
+61407128039
Fax 3267 0
Email 3267 0
j.fraser@uq.edu.au

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