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Smart Capnography Respiratory Index in Post Anesthesia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659516
Recruitment Status : Unknown
Verified April 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Information provided by:
Shaare Zedek Medical Center

Brief Summary:
The smart capnography respiratory index is a software tool that constitutes a representation of 4 parameters: End Tidal CO2, respiratory rate, O2 saturation and heart rate already displayed on a monitor in the form of a single respiratory index integer value ranging from 1 to 10 with trend information. The index is to be used to identify and display status and changes in patient respiratory status in a simple manner based on the summary of changes in the 4-above mentioned parameters. the respiratory index is to be used in varied clinical environments and is intended for use in adult and pediatric patients.

Condition or disease
Patients After Surgery and Anesthesia Monitored in the PACU

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Smart Capnography Respiratory Index: Clinical Evaluation
Study Start Date : May 2008
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : December 2008

intubated patients
non intubated patients

Primary Outcome Measures :
  1. To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the respiratory index evaluation will be performed on 40 patients (adult and pediatric) of which 30 will be non intubated

Inclusion Criteria:

  • Adult or pediatric patients after surgery and anesthesia, monitored in the PACU

Exclusion Criteria:

  • none

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 identifier (NCT number): NCT00659516

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Contact: Yaacov Gozal, MD 972-50-8685831

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Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Contact: Yaacov Gozal, MD    972-50-8685831   
Principal Investigator: Yaacov Gozal, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Yaacov Gozal, MD Shaare Zedek Medical center Jerusalem, Israel
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Responsible Party: Rachel Weissbrod, Oridion Medical 1987 Ltd Identifier: NCT00659516    
Other Study ID Numbers: 123
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008