Smart Capnography Respiratory Index in Post Anesthesia Patients

April 15, 2008 updated by: Shaare Zedek Medical Center

Smart Capnography Respiratory Index: Clinical Evaluation

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
intubated patients
2
non intubated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

August 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Estimate)

April 16, 2008

Last Update Submitted That Met QC Criteria

April 15, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • 123 (Giresun University Scientific Research Project)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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