Respiratory Insufficiency Clinical Trial
Official title:
Capnography Library - Data Collection in the Critical Care Environment Stage 2
Capgnography is the monitoring of the concentration or partial pressure of carbon dioxide in
the expired respiratory gases; as such, it is a non-invasive monitoring technique which
allows fast and reliable insight into ventilation, circulation and metabolism. Capnography
has proven to be more effective than clinical judgement alone in the early detection of
adverse respiratory events. The shape of a capnogram is identical in all humans with healthy
lungs; any deviations in shape must be investigated to determine a physiological or a
pathological cause of the abnormality.
Data from a previous pilot study yielded two major findings:
1. Prediction of requirement for intubation, by the creation of an "Integrated Pulmonary
Index" (IPI) based on non-invasive physiological parameters
2. Breathing patterns during weaning in order to identify specific patterns used to
predict extubation success/failure
The intent of the current study is to gather sufficient data to either prove or disprove the
findings of the previous study
The patient's monitoring period will be as follows:
Non-intubated patients - Initiation: As soon as possible after admission and/or extubation
and no later than 24 hours after either. Termination- either 2 hours after intubation or
after 8 hours of monitoring overall.
Intubated patients - Initiation: No later than 24 hours after a decision to begin weaning
has been made . Termination: Upon ICU (Intensive Care Unit) discharge or for the duration of
10 days at most.
Data will be collected using three tools:
1. CapnoStream raw data (CO2 (Carbon dioxide) waveform, EtCO2 (End-tidal Carbon dioxide),
respiratory rate, SpO2 (Saturation of peripheral Oxygen), pulse rate, IPI, alarms,
events and any other messages generated by the monitor) will be transferred from the
monitor to a laptop via a dedicated recording program.
2. Ventilator data (settings and resultant patient parameters) will be transferred from
the monitor to a laptop via a dedicated recording program.
3. Patient monitoring parameters (heart rate, blood pressure, CVP (Central Venous
Pressure), temperature, spirometry values etc) shall be recorded from the multi
parameter monitors already in use in the ICU and transferred online to a laptop using
dedicated recording software.
All recorded parameters will be synchronized. Data will be recorded from at least two of the
tools, the Capnostream and the ventilator.
;
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