Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation
NCT ID: NCT01572272
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
66 participants
OBSERVATIONAL
2012-08-31
2015-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Masked
Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Neonates who are ventilated with HFV
* Any significant medical condition which, at the investigator's discretion, may interfere with the study.
ALL
No
Sponsors
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Oridion
INDUSTRY
Responsible Party
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Principal Investigators
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Amir Kugelman, Prof.
Role: PRINCIPAL_INVESTIGATOR
Bnai Zion MC, Haifa Israel
Locations
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Soroka MC
Beersheba, , Israel
Bnai Zion MC
Haifa, , Israel
Shaare Zedek MC
Jerusalem, , Israel
Countries
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References
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Kugelman A, Golan A, Riskin A, Shoris I, Ronen M, Qumqam N, Bader D, Bromiker R. Impact of Continuous Capnography in Ventilated Neonates: A Randomized, Multicenter Study. J Pediatr. 2016 Jan;168:56-61.e2. doi: 10.1016/j.jpeds.2015.09.051. Epub 2015 Oct 17.
Other Identifiers
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D007157
Identifier Type: -
Identifier Source: org_study_id