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

NCT01572272 | Completed

• 1 other identifier: D007157
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 3

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.

Conditions

Intubated Neonates That Require Conventional Ventilation

Keywords

Distal Capnography; CO2; neonates; conventional ventilation

Outcome Measures

Primary Outcomes (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.

  Participants will be follwed throughout the duration of the ventilation. Estimated time: 14 days

  2 weeks

Study Arms (2)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intubated neonates that require conventional ventilation

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oridion: lead

Study Sites (3)

Soroka MC

Beersheba, Israel

Location

Bnai Zion MC

Haifa, Israel

Location

Shaare Zedek MC

Jerusalem, Israel

Location

Related Publications (1)

• Kugelman A, Golan A, Riskin A, Shoris I, Ronen M, Qumqam N, Bader D, Bromiker R. Impact of Continuous Capnography in Ventilated Neonates: A Randomized, Multicenter Study. J Pediatr. 2016 Jan;168:56-61.e2. doi: 10.1016/j.jpeds.2015.09.051. Epub 2015 Oct 17.

  PMID: 26490126 DERIVED

Study Officials

• Amir Kugelman, Prof.

  Bnai Zion MC, Haifa Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2012
• First Posted: April 6, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

IL (3)