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

Completed

• Conditions: Intubated Neonates That Require High Frequency Ventilation

• Registration Number: NCT01565226
• Lead Sponsor: Oridion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-25
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Study Start: 2012-08
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Soroka MC; 🇮🇱 Beer Sheva, Israel

Bnai Zion MC; 🇮🇱 Haifa, Israel

Shaare Zedek MC; 🇮🇱 Jerusalem, Israel