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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Oridion
Sponsor:
Information provided by (Responsible Party):
Oridion
ClinicalTrials.gov Identifier:
NCT01572272
First received: March 25, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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
Intubated Neonates That Require Conventional Ventilation

Study Type: Observational
Study Design: 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

Further study details as provided by Oridion:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Participants will be follwed throughout the duration of the ventilation. Estimated time: 14 days


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572272

Contacts
Contact: Amir Kugelman, Prof 972-4-8359063 dramir@netvision.net.il

Locations
Israel
Soroka MC Recruiting
Beer Sheva, Israel
Contact: Agi Golan, MD    972-8-6400508    agneta@bgumail.ac.il   
Principal Investigator: Agi Golan, MD         
Bnai Zion MC Recruiting
Haifa, Israel
Contact: Amir Kugelman, Prof.    972-4-8359063    dramir@netvision.net.il   
Principal Investigator: Amir Kugelman, Prof.         
Shaare Zedek MC Recruiting
Jerusalem, Israel
Contact: Reuben Brumiker, MD    972-2-6666161    bromi@szmc.org.il   
Principal Investigator: Reuben Bromiker, MD         
Sponsors and Collaborators
Oridion
Investigators
Principal Investigator: Amir Kugelman, Prof. Bnai Zion MC, Haifa Israel
  More Information

No publications provided

Responsible Party: Oridion
ClinicalTrials.gov Identifier: NCT01572272     History of Changes
Other Study ID Numbers: D007157
Study First Received: March 25, 2012
Last Updated: August 14, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Oridion:
Distal Capnography
CO2
neonates
conventional ventilation

ClinicalTrials.gov processed this record on August 28, 2014