Trials / Completed
CompletedNCT01572272
Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation
Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation. A Randomized, Multi-Center Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 66 (actual)
- Sponsor
- Oridion · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2012-04-06
- Last updated
- 2016-11-02
Locations
3 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT01572272. Inclusion in this directory is not an endorsement.