Capnography in Neonates Ventilated With High Frequency Ventilation: Prospective, Observational Multi-Center Study

Oridion

Status: Completed

Conditions: Intubated Neonates That Require High Frequency Ventilation

Study type: Observational

Funder types: Industry

Identifiers

NCT01565226

D007171

Details and patient eligibility

About

• This will be an observational study. Respiratory data will be recorded using Capnostream20p. There will be no use in the recorded data for the medical care of the patients. Other clinical data will be captured in the CRF. Similar study is currently conducted in Bnai Zion MC since 2008. Thirty four (34) patients have been recruited without any adverse events.
• During the study the medical team will capture in the CRF the following: Blood gas and distal capnography values at time of sampling, ventilator settings at time of sampling.
• Changes made in the ventilation parameters, blood gas time and results, concomitant treatment (e.g. suction) and concomitant medication (respiratory related e.g. surfactant), vital signs all these will be retrieved from the patient's medical charts.

Enrollment: 25 patients

Sex: All

Ages: 1+ day old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intubated neonates with double-lumen ETT (Uncuffed Tracheal Tube, Mallinckrodt Inc., Chih, Mexico)
• Neonates that their respiratory condition requires HFV
• Neonates expected to have at least 3 pairs of distal capnography measurements and blood gas samplings.

Exclusion criteria

• Intubated neonates with single-lumen ETTs
• Neonates who are ventilated with conventional ventilation
• Any significant medical condition which, at the investigator's discretion, may interfere with the study.

Trial design

25 participants in 1 patient group

Open

Description:

open, observational study