Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565226
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG ( 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.

Condition or disease
Intubated Neonates That Require High Frequency Ventilation

Layout table for study information
Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Capnography in Neonates Ventilated With High Frequency Ventilation: Prospective, Observational Multi-Center Study
Study Start Date : August 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort
Open
open, observational study



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565226


Locations
Layout table for location information
Israel
Soroka MC
Beer Sheva, Israel
Bnai Zion MC
Haifa, Israel
Shaare Zedek MC
Jerusalem, Israel
Sponsors and Collaborators
Oridion
Investigators
Layout table for investigator information
Principal Investigator: Amir Kugelman, Prof. Bnai Zion MC, Haifa Israel
Layout table for additonal information
Responsible Party: Oridion
ClinicalTrials.gov Identifier: NCT01565226    
Other Study ID Numbers: D007171
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Keywords provided by Medtronic - MITG ( Oridion ):
Capnography
CO2
neonates
High Frequency ventilation (HFV)