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

Oridion3 sites in 1 country25 target enrollmentAugust 2012

ConditionsIntubated Neonates That Require High Frequency Ventilation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intubated Neonates That Require High Frequency Ventilation
Sponsor: Oridion
Enrollment: 25
Locations: 3
Primary Endpoint: Evaluate the feasibility of measuring distal capnography on HFV and to assess its correlation and agreement with PaCO2 in infants ventilated with HFV in a prospective study.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

February 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Oridion

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Evaluate the feasibility of measuring distal capnography on HFV and to assess its correlation and agreement with PaCO2 in infants ventilated with HFV in a prospective study.

Time Frame: August 2012 - February 2015