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Capnography Library - Data Collection in the Critical Care Environment Stage 2

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ClinicalTrials.gov Identifier: NCT01354769
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

Brief Summary:

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


Condition or disease Intervention/treatment
Respiratory Insufficiency Device: CapnoStream20

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Capnography Library - Data Collection in the Critical Care Environment Stage 2
Study Start Date : June 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care
U.S. FDA Resources

Group/Cohort Intervention/treatment
Non-intubated patients Device: CapnoStream20
The monitor used for data gathering is a CapnoStream20-multi parameter monitor
Other Name: Capnostream Bedside Monitor, Oridion Medical Ltd.
Intubated patients Device: CapnoStream20
The monitor used for data gathering is a CapnoStream20-multi parameter monitor
Other Name: Capnostream Bedside Monitor, Oridion Medical Ltd.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-intubated and intubated patients being treated for severe illnesses in the intensive care unit
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354769


Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Sharon Einav-Bromiker, MD Shaare Zedek Medical Centre

Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01354769     History of Changes
Other Study ID Numbers: D0006746A
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: May 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases