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

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ClinicalTrials.gov Identifier: NCT01572272
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG ( Oridion )

Brief 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.

Condition or disease
Intubated Neonates That Require Conventional Ventilation

Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation. A Randomized, Multi-Center Study
Study Start Date : August 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort
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.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intubated neonates that require conventional ventilation
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572272


Locations
Israel
Soroka MC
Beer Sheva, Israel
Bnai Zion MC
Haifa, Israel
Shaare Zedek MC
Jerusalem, Israel
Sponsors and Collaborators
Oridion
Investigators
Principal Investigator: Amir Kugelman, Prof. Bnai Zion MC, Haifa Israel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oridion
ClinicalTrials.gov Identifier: NCT01572272     History of Changes
Other Study ID Numbers: D007157
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Medtronic - MITG ( Oridion ):
Distal Capnography
CO2
neonates
conventional ventilation