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

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

About this 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:

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.
Ventilator data (settings and resultant patient parameters) will be transferred from the monitor to a laptop via a dedicated recording program.
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Over the age of 18
Suffering from severe illness requiring admission to the ICU
Expected to be hospitalized in the ICU for a minimum of 8 hours

Exclusion criteria

Under the age of 18
The patient's refusal to participate in the study
Any change in the patient's condition that may interfere with data collection

Treatment and study plan

CapnoStream20

Device

The monitor used for data gathering is a CapnoStream20-multi parameter monitor

Other names: Capnostream Bedside Monitor, Oridion Medical Ltd.

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: May 17, 2011
Registry last updated: Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed