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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be follwed throughout the duration of the ventilation. Estimated time: 14 days | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Intubated neonates that require conventional ventilation
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| Name | Affiliation | Role |
|---|---|---|
| Amir Kugelman, Prof. | Bnai Zion MC, Haifa Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka MC | Beersheba | Israel | ||||
| Bnai Zion MC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26490126 | Derived | 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. |
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| Haifa |
| Israel |
| Shaare Zedek MC | Jerusalem | Israel |