Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients (IMPROVE)
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|ClinicalTrials.gov Identifier: NCT03967587|
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : January 26, 2021
The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit.
Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine.
The infants will remain in the study as long as the Neosense measuring system is used.
|Condition or disease||Intervention/treatment||Phase|
|Catheters Oxygen Saturation Newborn, Infant, Disease||Device: Neosense Umbilical Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients|
|Actual Study Start Date :||November 19, 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
|Experimental: Neosense Umbilical Catheter||
Device: Neosense Umbilical Catheter
The Neosense umbilical catheter is used instead of the routinely used umbilical catheter
- Measurement performance of an intravascular oxygen sensor in the Neosense system. [ Time Frame: Average of measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days) ]The oxygen tension measured by the Neosense system, compared to the oxygen tension measured by a blood gas analyser.
- Clinical complications with the Neosense catheter. [ Time Frame: During study, up to 8 days ]The number of occasions when the Neosense catheter had to be removed and the underlying reason. This includes all anticipated device effects as well as placing the catheter in the wrong vessel, impossible to measure blood pressure, collect blood samples and/or administer fluids.
- Any deviations from normal procedures when inserting an umbilical catheter. [ Time Frame: During day 1 ]Number of attempts to place the catheter for each patient. Any accessories needed to introduce or handle the Neosense catheter.
- Number of monitor lockups or battery depletions [ Time Frame: During study, in average 4-5 days ]Timepoint for monitor lockup or battery depletion, in case of occurrence.
- Usability and functionality of the Neosense monitor. [ Time Frame: During study, in average 4-5 days ]Occurence of anticipated adverse device effects for the monitor.
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): NCT03967587
|Contact: Principal Investigator||+46 8 517 700 email@example.com|
|Karolinska University Hospital||Recruiting|
|Contact: Mats B Blennow|
|Principal Investigator:||Mats B Blennow, MD, Prof.||Karolinska University Hospital|