Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation
November 1, 2016 updated by: Oridion
Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation. A Randomized, Multi-Center Study
Primary:
The purpose of this study is to assess the clinical implications of continuous distal CO2 monitoring when used for clinical decisions
Sub Study:
• Evaluate the average life time (duration) of Standard Carinal VitaLine set in comparison to the Carinal VitaLine set that its sampling tubing is made of PEBAX (dehumidifying material).
Description of Study Design:
Patients will be randomized at the baseline evaluation visit into one of the following groups:
- Masked group: Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it.
- Open group: Data derived from the Capnostream20p and displayed to the medical team. It will allow the treating physician and the nursing team to review the real time data and make clinical decisions based upon it if felt necessary.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
66
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
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Beer Sheva, Israel
- Soroka MC
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Haifa, Israel
- Bnai Zion Mc
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Jerusalem, Israel
- Shaare Zedek Mc
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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
Intubated neonates that require conventional ventilation
Description
Inclusion Criteria:
- Intubated neonates with double-lumen ETT (Uncuffed Tracheal Tube, Mallinckrodt Inc., Chih, Mexico) that their respiratory condition requires conventional ventilation.
- Obtaining signed Informed Consent Form by the parents or legal guardian
- Intubated neonates that are expected to provide at least 3 pairs of blood samples and ETCO2 measurements during ventilation period
Exclusion Criteria:
- Intubated neonates with single-lumen ETTs
- Neonates who are ventilated with HFV
- Any significant medical condition which, at the investigator's discretion, may interfere with the study.
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 |
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Open
Open group: Data derived from the Capnostream20p and displayed to the medical team.
It will allow the treating physician and the nursing team to review the real time data and make clinical decisions based upon it if felt necessary.
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Masked
Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Compare between the open and the masked group in the following: the percentage of measurement points at the Safe range: 60>PaCO2>30, Normal range 45>PaCO2>35 and Adequate (permissive) range: 45-55.
Time Frame: 2 weeks
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Participants will be follwed throughout the duration of the ventilation.
Estimated time: 14 days
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amir Kugelman, Prof., Bnai Zion MC, Haifa Israel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
August 1, 2012
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
March 25, 2012
First Submitted That Met QC Criteria
April 4, 2012
First Posted (Estimate)
April 6, 2012
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- D007157
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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