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

Oridion

Status: Completed

Conditions: Intubated Neonates That Require Conventional Ventilation

Study type: Observational

Funder types: Industry

Identifiers

NCT01572272

D007157

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

66 participants in 2 patient groups

Open

Description:

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

Description:

Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it.