Smart Capnography Respiratory Index in Post Anesthesia Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00659516
First received: April 14, 2008
Last updated: April 15, 2008
Last verified: April 2008
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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
1
intubated patients
2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Rachel Weissbrod, Oridion Medical 1987 Ltd
ClinicalTrials.gov Identifier: NCT00659516     History of Changes
Other Study ID Numbers: 123
Study First Received: April 14, 2008
Last Updated: April 15, 2008
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 August 28, 2014