Smart Capnography Respiratory Index in Post Anesthesia Patients

Patients After Surgery and Anesthesia Monitored in the PACU Clinical Trial

Official title:

Smart Capnography Respiratory Index: Clinical Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00659516
• Other study ID #: 123
• Status: Not yet recruiting
• Phase: N/A
• First received: April 14, 2008
• Last updated: April 15, 2008
• Start date: May 2008
• Est. completion date: December 2008

Study information

• Verified date: April 2008
• Source: Shaare Zedek Medical Center
• Contact: Yaacov Gozal, MD
• Phone: 972-50-8685831
• Email: gozaly[@]szmc.org.il
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIsrael: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Patients After Surgery and Anesthesia Monitored in the PACU

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients		3 months	No