NCT Number: NCT01572272
Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation
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.
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Sex eligibility
All sexes
Study type
Observational
Primary location
Soroka MC, Beersheba, Israel
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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
Participants will be follwed throughout the duration of the ventilation. Estimated time: 14 days
Sponsors and collaborators
Lead sponsor
Oridion
Industry
Registry information
Official study title
Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation. A Randomized, Multi-Center Study
Important dates
- Study start
- 2012
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 6, 2012
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.