Smart Capnography Respiratory Index in Post Anesthesia Patients - Full Text View

Smart Capnography Respiratory Index in Post Anesthesia Patients

This study is not yet open for participant recruitment.
Verified by Shaare Zedek Medical Center, April 2008

Sponsored by:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00659516

Purpose

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

Patients After Surgery and Anesthesia Monitored in the PACU

MedlinePlus related topics:

Anesthesia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Smart Capnography Respiratory Index: Clinical Evaluation

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts

intubated patients

non intubated patients

Eligibility

Genders Eligible for Study:	Both
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659516

Contacts


Contact: Yaacov Gozal, MD	972-50-8685831	gozaly@szmc.org.il

Locations


Israel
	Shaare Zedek Medical Center	Not yet recruiting
	Jerusalem, Israel, 91031
	Contact: Yaacov Gozal, MD 972-50-8685831 gozaly@szmc.org.il
	Principal Investigator: Yaacov Gozal, MD

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators


Principal Investigator:	Yaacov Gozal, MD	Shaare Zedek Medical center Jerusalem, Israel

More Information

Responsible Party:	Oridion Medical 1987 Ltd ( Rachel Weissbrod )
Study ID Numbers:	123
First Received:	April 14, 2008
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00659516
Health Authority:	United States: Institutional Review Board; Israel: The Israel National Institute for Health Policy Research and Health Services Research

ClinicalTrials.gov processed this record on October 17, 2008