Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000452099
Ethics application status
Approved
Date submitted
27/05/2009
Date registered
3/06/2010
Date last updated
26/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of lung derecruitment resulting from suction of the endotracheal tube in ventilated preterm infants
Scientific title
The effect of endotracheal tube suction on lung derecruitment in ventilated preterm infants
Secondary ID [1] 251930 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventilated preterm infants 4863 0
Condition category
Condition code
Respiratory 237215 237215 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The intervention consists of removal of the flow sensor followed by suctioning via a Bodai suction port using a 6-F catheter in infants on conventional ventilation. Each suction procedure will consist of approximately and will consist of 2 suction passes and conclude with re-insertion of the flow sensor back into the ventilatory circuit. Only one suction intervention will be measured and the entire procedure will take a maximum of 10 minutes.
Intervention code [1] 236645 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238025 0
Ventilation distribution using electrical impedance tomography (EIT).
Timepoint [1] 238025 0
EIT measurements will be taken for 60 seconds before suction, and at 15, 30, 45, 60, 75, 90 105, 120 minutes post suction.
A 10 minute EIT measurement will be taken during suction.
Secondary outcome [1] 242169 0
Physiological parameters such as heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP).
Ventilator parameters using the Draegar ventview program will be downloaded from the ventilator Oxygenation
Timepoint [1] 242169 0
Ventilator parameters and physiological variables will be downloaded continuously from before suction and continue until 2 hours post suction.

Eligibility
Key inclusion criteria
Gestation less than 32 weeks gestation (i.e. up to and including 31 weeks 6 days gestation)
Less than 7 days of age at onset of endotracheal ventilation
Birth weight of more than 750 grams
Duration of ventilation at enrolment of at least 12 hours
Expected to continue to receive mechanical ventilation before and after at least one episode of airway suction after enrolment
Satisfactory endotracheal tube position has been determined by chest radiograph
Arterial sampling line in situ (umbilical or extremity)
Parent(s) able and willing to provide informed consent
Minimum age
No limit
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Air leak syndrome (e.g. pneumothorax, pneumomediastinum, pulmonary interstitial emphysema
Lung or cardiovascular anomaly that would substantially affect oxygenation, lung recruitment or regional ventilation, e.g;
o cyanotic or other major congenital heart disease (not including Patent Ductus Arteriosus)
o tracheo-oesphageal fistula
o space occupying thoracic lesion such as diaphragmatic hernia or eventration, or cystic adenomatoid malformation
Substantial leak around endotracheal tube (e.g.. >50%) precluding accurate non-invasive measurement of respiratory function
Significant hemodynamic instability (untreated shock, hypovolemia, hypotension)
Poor skin integrity precluding the use of adhesive electrocardiogram (ECG) electrodes.
Survival considered unlikely (death considered imminent or inevitable).
Both parents of baby under 18 years of age due to the complexities of obtaining consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/11/2008
Actual
10/11/2008
Date of last participant enrolment
Anticipated
Actual
9/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5027 0
Charities/Societies/Foundations
Name [1] 5027 0
Australia and New Zealand (ANZ) Trustees Childrens Medical Research Establishment Grant
Country [1] 5027 0
Australia
Primary sponsor type
Individual
Name
Judy Hough
Address
Physiotherapy Department
Mater Health Services
Raymond Terrace
South Brisbane
Queensland
4101
Country
Australia
Secondary sponsor category [1] 4544 0
None
Name [1] 4544 0
Address [1] 4544 0
Country [1] 4544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239124 0
Mater Health Services
Ethics committee address [1] 239124 0
Ethics committee country [1] 239124 0
Australia
Date submitted for ethics approval [1] 239124 0
Approval date [1] 239124 0
14/08/2008
Ethics approval number [1] 239124 0
1209M
Ethics committee name [2] 259127 0
Mater Health Human Research Ethics Committee
Ethics committee address [2] 259127 0
Ethics committee country [2] 259127 0
Date submitted for ethics approval [2] 259127 0
Approval date [2] 259127 0
Ethics approval number [2] 259127 0

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

Contacts
Principal investigator
Name 29653 0
Dr Judith Hough
Address 29653 0
Physiotherapy Department
Mater Health Services
Raymond Terrace
South Brisbane
QLD 4101
Country 29653 0
Australia
Phone 29653 0
61 422404369
Fax 29653 0
Email 29653 0
judyhough@optusnet.com.au
Contact person for public queries
Name 12900 0
Judy Hough
Address 12900 0
Paediatric Critical Care Research Group
Mater Health Services
Raymond Terrace
South Brisbane
Queensland
4101
Principal Investigator
Country 12900 0
Australia
Phone 12900 0
+61 422404369
Fax 12900 0
+61 7 31631642
Email 12900 0
judyhough@optusnet.com.au
Contact person for scientific queries
Name 3828 0
Judy Hough
Address 3828 0
Paediatric Critical Care Research Group
Mater Health Services
Raymond Terrace
South Brisbane
Queensland
4101
Principal Investigator
Country 3828 0
Australia
Phone 3828 0
+61 422404369
Fax 3828 0
+61 7 31631642
Email 3828 0
judyhough@optusnet.com.au

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.