Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation

Study Overview
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Brief Summary
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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: 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.

Official Title
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Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation. A Randomized, Multi-Center Study

Conditions
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Intubated Neonates That Require Conventional Ventilation

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open<br>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<br>Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Capnography, CO2, neonates, conventional ventilation