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Smart Capnography Respiratory Index in Post Anesthesia Patients

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ClinicalTrials.gov Identifier: NCT00659516
Recruitment Status : Unknown
Verified April 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Tracking Information
First Submitted Date April 14, 2008
First Posted Date April 16, 2008
Last Update Posted Date April 16, 2008
Study Start Date May 2008
Estimated Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2008)
To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients [ Time Frame: 3 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Smart Capnography Respiratory Index in Post Anesthesia Patients
Official Title Smart Capnography Respiratory Index: Clinical Evaluation
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Patients After Surgery and Anesthesia Monitored in the PACU
Intervention Not Provided
Study Groups/Cohorts
  • 1
    intubated patients
  • 2
    non intubated patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 15, 2008)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2008
Estimated Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00659516
Other Study ID Numbers 123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rachel Weissbrod, Oridion Medical 1987 Ltd
Study Sponsor Shaare Zedek Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Yaacov Gozal, MD Shaare Zedek Medical center Jerusalem, Israel
PRS Account Shaare Zedek Medical Center
Verification Date April 2008