Change of Respiratory Function during Extracorporeal Life Support (ECLS), a Pilot Study to identify Pulmonary Predictors of Outcome

Change of Respiratory Function in Children during ECLS, a Pilot Study to identify Pulmonary Predictors of Outcome

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616000688482

Enrollment

Registered

2016-05-26

Start date

2017-11-15

Completion date

2018-10-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

0 to 18 Years

Healthy volunteers

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.

Exclusion criteria

None

Outcome results