Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000688482
Ethics application status
Approved
Date submitted
17/05/2016
Date registered
26/05/2016
Date last updated
18/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Change of Respiratory Function during Extracorporeal Life Support (ECLS), a Pilot Study to identify Pulmonary Predictors of Outcome
Scientific title
Change of Respiratory Function in Children during ECLS, a Pilot Study to identify Pulmonary Predictors of Outcome
Secondary ID [1] 289237 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory failure 298809 0
Cardiac failure 298847 0
Condition category
Condition code
Respiratory 298857 298857 0 0
Other respiratory disorders / diseases
Cardiovascular 298858 298858 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Pulmonary function data will be collected, including measures of electrical impedance tomography (EIT) which, will be performed on a once daily base whilst the patient is on ECLS and the day after weaning off ECLS. The EIT will measure pulmonary function when the patient is on standard ventilation settings. An example of typical ventilation setting for a patient on ECLS are:
Mode:Pressure Controlled Ventilation (PC)
Positive End-Expiratory Pressure [mbar] (PEEP): 10
Peak Inspiratory Pressure [mbar] (PIP): 20
Tidal Volume (Vt)[mL/kg]: Not Applicable
Respiratory Rate [bpm] (RR): 10-15
Fraction of Inspired Oxygen (FiO2): 0.4
Inspiration Time [sec] (Ti):1
Pressure Support [mbar] (PS): Not applicable

Lung recruitment will can be undertaken on patients on ECLS for both respiratory and cardiac conditions, however remains at the discretion of the daily treating team. These function test maneuvers taken 30minutes. The pressure ramp is set according to the patient's age. Hysteresis, upper and lower inflection points, resistance and compliance values will be recorded, The maximal pressure ramp settings are as follows:
0-1 years- 30 mbar
2-5 years- 35 mbar
>5 years- 45 mbar

This pulmonary function data will be collected once daily for the duration of the ECLS run and one day following cessation of ECLS. There is no maximum follow-up period.
Intervention code [1] 294774 0
Early Detection / Screening
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298334 0
We intend to use our standard approach to explore all possible EIT parameters including respiratory mechanic data of the ventilator to identify predictors of successful ECLS treatment and recovery of the lung. A change of 20% from baseline is generally accepted as a clinical important change in pulmonary function tests. This will be determined through review of the collected data (see below).

The pulmonary function measures to be collected include:

Ventilation: tidal volume, tidal volume/kg, respiratory rate, FiO2, PEEP, PIP, PS, Ti, Compliance, Resistance, MAP, Amplitude, Frequency.
PV Curve: Max. Pressure Ramp, Compliance Stat, Volume recruitment, Slope.
EIT: End-expiratory level (EEL) Global, EEL Anterior, EEL Posterior, Amplitude Global, Amplitude Anterior, Amplitude Posterior, F-Index, GI Index, Profiles, Perfusion index.

This data will be collected on a data collection form, from the patient's medical records and directly from the ventilator.
Timepoint [1] 298334 0
Data will be collected from the recruited patients once daily for the duration of ECLS and once daily one day following weaning off ECLS
Secondary outcome [1] 323873 0
Not applicable
Timepoint [1] 323873 0
Not applicable

Eligibility
Key inclusion criteria
This study will include patients that require extracorporeal life support (ECLS) for both respiratory and/or cardiac failure. The plan for enrollment is to capture patients from day 1 of the ECLS run. This allows for greater data collection to determine if there is a trend in pulmonary function indicators.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We will use an ANOVA with Bonferroni correction for repeated measurements and analyze data with a general mixed model, if one of the lung function parameters at any given point of ECLS treatment predicts outcome. The patients will be stratified into ECLS for cardiac and respiratory conditions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2017
Actual
15/11/2017
Date of last participant enrolment
Anticipated
1/10/2018
Actual
Date of last data collection
Anticipated
1/12/2018
Actual
Sample size
Target
50
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5805 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 13247 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 293614 0
Other
Name [1] 293614 0
Paediatric Critical Care Research Group
Country [1] 293614 0
Australia
Primary sponsor type
Hospital
Name
Lady Cilento Children's Hospital
Address
501 Stanley Street
South Brisbane
QLD, 4101
Country
Australia
Secondary sponsor category [1] 292433 0
Other
Name [1] 292433 0
Paediatric Critical Care Research Group
Address [1] 292433 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane, QLD 4101
Country [1] 292433 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295055 0
Children's Health Service Human Research Ethics Committee
Ethics committee address [1] 295055 0
Children's Health Queensland Human Research Ethics Committee,
Level 7, Centre for Children's Health Research, Lady Cilento Children's Hospital Precinct,
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 295055 0
Australia
Date submitted for ethics approval [1] 295055 0
06/06/2016
Approval date [1] 295055 0
30/06/2016
Ethics approval number [1] 295055 0
HREC/16/QRCH/213

Summary
Brief summary
Pulmonary function tests including measures of electrical Impedance tomography (EIT) will be performed on a daily base whilst the patient is on Extracorporeal Life Support (ECLS) and preferentially one day after weaning off ECLS.The following proposed interventions and pulmonary function tests are part of our current standard treatment protocol and used for clinical assessment of patients on ECLS, except for the use of EIT. To facilitate easier use of the EIT system and measurement of pulmonary function tests, patients will be transitioned to a Hamilton G5 ventilator, which gives an easier access and download of pulmonary function data than our current fleet of ventilators (Evita XL, Servo I and Servo U). Mode and ventilation delivery of the Hamilton G5 ventilator is no different to our standard fleet. Based on the findings a potential interventional trial will be conducted investigating whether a different ventilation strategy on ECLS may improve outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65918 0
A/Prof Andreas Schibler
Address 65918 0
Lady Cilento Children's Hospital
501 Stanley Street South Brisbane QLD 4101
Country 65918 0
Australia
Phone 65918 0
+61 7 3068 5733
Fax 65918 0
Email 65918 0
[email protected]
Contact person for public queries
Name 65919 0
Andreas Schibler
Address 65919 0
Lady Cilento Children's Hospital
501 Stanley Street South Brisbane QLD 4101
Country 65919 0
Australia
Phone 65919 0
+61 7 3068 5733
Fax 65919 0
Email 65919 0
[email protected]
Contact person for scientific queries
Name 65920 0
Andreas Schibler
Address 65920 0
Lady Cilento Children's Hospital
501 Stanley Street South Brisbane QLD 4101
Country 65920 0
Australia
Phone 65920 0
+61 7 3068 5733
Fax 65920 0
Email 65920 0
[email protected]

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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