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

NCT01572272 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2016-11-02

No results posted yet for this study

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

  • Intubated Neonates That Require Conventional Ventilation

Sponsors & Collaborators

  • Oridion

    lead INDUSTRY

Principal Investigators

  • Amir Kugelman, Prof. · Bnai Zion MC, Haifa Israel

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01572272 on ClinicalTrials.gov