Intubated Neonates That Require High Frequency Ventilation Clinical Trial
Official title:
Capnography in Neonates Ventilated With High Frequency Ventilation: Prospective, Observational Multi-Center Study
| Verified date | November 2016 |
| Source | Medtronic - MITG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
- 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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Soroka MC | Beer Sheva | |
| Israel | Bnai Zion MC | Haifa | |
| Israel | Shaare Zedek MC | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Oridion |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |