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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01565226
Enrollment
25
Registered
2012-03-28
Start date
2012-08-31
Completion date
2015-02-28
Last updated
2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubated Neonates That Require High Frequency Ventilation

Keywords

Capnography, CO2, neonates, High Frequency ventilation (HFV)

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.

Interventions

None listed

Sponsors

Oridion
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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.August 2012 - February 2015

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026