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

This study is currently recruiting participants.
Verified May 2011 by Shaare Zedek Medical Center
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01354769
First received: May 16, 2011
Last updated: May 30, 2012
Last verified: May 2011
History of Changes
  Purpose

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 Intervention
Respiratory Insufficiency
 Device: CapnoStream20

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Capnography Library - Data Collection in the Critical Care Environment Stage 2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Estimated Enrollment: 75
Study Start Date: June 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354769

Contacts
Contact: Sharon Einav, MD 972-2-666-6664 einav_s@szmc.org.il
Contact: Iris Shalev-Stein, Dr 972-2-589-9186 iris.shalev@oridion.com

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Sharon Einav, MD     972-2-666-6664     einav_s@szmc.org.il    
Principal Investigator: Sharon Einav, MD            
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Sharon Einav-Bromiker, MD Shaare Zedek Medical Centre
  More Information

No publications provided

Responsible Party: Sharon Einav, MD, Shaare Zedek Medical Centre
ClinicalTrials.gov Identifier: NCT01354769     History of Changes
Other Study ID Numbers: D0006746A
Study First Received: May 16, 2011
Last Updated: May 30, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013