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Trial registered on ANZCTR


Registration number
ACTRN12610000167066
Ethics application status
Approved
Date submitted
15/02/2010
Date registered
19/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
In very preterm infants who are being extubated to nasal continuous positive airway pressure (CPAP), does a continuous positive airway pressure (CPAP) recruitment maneuvre post extubation improve global and regional end-expiratory lung volume, thoracoabdominal asynchrony and work of breathing when compared to no recruitment maneuvre?
Scientific title
In very preterm infants who are being extubated to nasal continuous positive airway pressure (CPAP), does a continuous positive airway pressure (CPAP) recruitment maneuvre post extubation improve global and regional end-expiratory lung volume, thoracoabdominal asynchrony and work of breathing when compared to no recruitment maneuvre?
Secondary ID [1] 1424 0
None
Universal Trial Number (UTN)
U1111-1113-6435
Trial acronym
The CPAP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome 256816 0
Condition category
Condition code
Respiratory 256968 256968 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial comparing a CPAP recruitment maneuvre in very preterm infants < 32weeks gestation who are being extubated to nasal CPAP. Eligible infants randomised to a CPAP recruitment maneuvre will be extubated to a CPAP pressure of 6cmH2O.This will be increased to a CPAP pressure of 8cm H2O and then 10 cm H2O over 5 mins. The infant will be maintained at 10 cm H2O for 15 mins before being returned to CPAP pressure of 6cmH2O. This maneuvre will only occur once post extubation.
Intervention code [1] 256024 0
Treatment: Other
Intervention code [2] 256048 0
Treatment: Devices
Comparator / control treatment
Control treatment is current clinical management - infants are extubated to nasal CPAP as per clinician choice with no recruitment maneuvre
Control group
Active

Outcomes
Primary outcome [1] 257852 0
Regional lung volume and tidal ventilation will be measured using GoeMF II Electrical Impedance Tomography (EIT) system (Cardinal Healthcare, Gottingen, Germany). Electrical Impedance Tomography is a non-invasive, radiation-free tool that allows real-time imaging of global and regional lung function and allows assessment of tidal ventilation on a breath-by-breath basis within different regions of the lung. It is based on the measurement of electrical voltages resulting from the injection of very small electrical currents continuously measured on the thoracic circumference using 16 conventional surface electrodes. The difference in the voltage between the transmitting and receiving current represents the impedance change and is proportional to change in lung volume.
Timepoint [1] 257852 0
Baseline (while intubated) then during extubation and then at 5, 20, 35, 50, 65, 80, 95 and 120mins from extubation and commencement of CPAP.
Secondary outcome [1] 263301 0
Changes in end-expiratory lung volume, tidal volume, thoraco-abdominal synchrony and work of breathing will be measured using Respiratory Inductive Plethysmography (RIP) (Non-invasive Monitoring systems Inc, Tampa, FL, USA). This involves placing 2 sinusoidal shielded wires embedded in elastic material (Respiband Plus, Sensor Medics, CA, USA) placed around the rib cage (at nipple level) and abdomen (at umbilical level). Oesophageal pressure (Poes) will be measured as a proxy for trans-pulmonary pressure. Poes will be measured using a balloon pressure transducer either embedded into a stand-alone 5FG or 6FG neonatal oesophageal catheter or a dual-function 7FG feeding tube/oesophageal catheter (Bicore, Cardinal Healthcare, Netherlands). Choice of catheter will depend on infant size.
Timepoint [1] 263301 0
Baseline (while intubated) then during extubation and then at 5, 20, 35, 50, 65, 80, 95 and 120mins from extubation and commencement of CPAP.

Eligibility
Key inclusion criteria
Ventilated infants less than 32 weeks gestational age who are being extubated to nasal CPAP who have an inspired fraction of oxygen (FiO2) requirement < 0.4 to maintain saturations 88-92%
Minimum age
24 Weeks
Maximum age
32 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants will be excluded if they are at risk of being intubated secondary to increasing FiO2 requirements or have multiple episodes of apnoea requiring stimulation; are at risk of being intubated in the next 2-3 hours post-extubation; are receiving NIPPV (non-invasive positive pressure ventilation; have a major congenital anomaly that might have an adverse effect on breathing or ventilation, apart from prematurity or asphyxia; are too unstable for routine nursing and have skin that is too fragile for conventional ECG electrode placement

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)
Prior informed consent from an eligible infant's parents will be obtained before enrolling a subject. Infants will be randomised by opening a sequentially numbered sealed opaque envelopes containing the allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
These will be prepared by a study statistician using variable block sizes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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] 256524 0
Government body
Name [1] 256524 0
National Health and Medical Research Council Program Grant
Address [1] 256524 0
GPO Box 1421
Canberra
ACT 2601
Country [1] 256524 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Davis
Address
Neonatal Services
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 255833 0
None
Name [1] 255833 0
Address [1] 255833 0
Country [1] 255833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258572 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 258572 0
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
VIC 3052
Ethics committee country [1] 258572 0
Australia
Date submitted for ethics approval [1] 258572 0
Approval date [1] 258572 0
16/09/2009
Ethics approval number [1] 258572 0
09/39

Summary
Brief summary
Very preterm infants are particularly susceptible to ventilator induced lung injury and methods of non-invasive respiratory support, the commonest being CPAP are known to reduce the risk of lung injury. However, the optimal pressure levels remain to be determined.

Will very preterm infants with respiratory distress syndrome who are being extubated to CPAP initially need higher CPAP pressures than are usually used in order to restore and maintain lung volume?

Our hypothesis is that infants extubated to nasal CPAP will initially need higher CPAP pressures than the mean airway pressure delivered by the ventilator prior to extubation in order to restore and maintain lung volume
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30847 0
Address 30847 0
Country 30847 0
Phone 30847 0
Fax 30847 0
Email 30847 0
Contact person for public queries
Name 14094 0
Risha Bhatia
Address 14094 0
The Royal Women's Hospital
Neonatal Services
Cnr Grattan Street and Flemington Road
Parkville VIC 3052
Country 14094 0
Australia
Phone 14094 0
+61 3 83453773
Fax 14094 0
+61 3 8345 3789
Email 14094 0
risha.bhatia@thewomens.org.au
Contact person for scientific queries
Name 5022 0
Risha Bhatia
Address 5022 0
The Royal Women's Hospital
Neonatal Services
Cnr Grattan Street and Flemington Road
Parkville VIC 3052
Country 5022 0
Australia
Phone 5022 0
+61 3 83453773
Fax 5022 0
+61 3 8345 3789
Email 5022 0
risha.bhatia@thewomens.org.au

No information has been provided regarding IPD availability
Summary results
No Results