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Smart Capnography Respiratory Index in Post Anesthesia Patients

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00659516
Collaborator
(none)
40
Enrollment
1
Location
7
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Smart Capnography Respiratory Index: Clinical Evaluation
    Study Start Date :
    May 1, 2008
    Anticipated Primary Completion Date :
    Aug 1, 2008
    Anticipated Study Completion Date :
    Dec 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    1

    intubated patients
    2

    non intubated patients

    Outcome Measures

    Primary Outcome Measures

    1. To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult or pediatric patients after surgery and anesthesia, monitored in the PACU
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shaare Zedek Medical Center Jerusalem Israel 91031

    Sponsors and Collaborators

    • Shaare Zedek Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00659516
    Other Study ID Numbers:
    • 123
    First Posted:
    Apr 16, 2008
    Last Update Posted:
    Apr 16, 2008
    Last Verified:
    Apr 1, 2008

    Study Results

    No Results Posted as of Apr 16, 2008