Condition: Respiratory Failure · Sponsor: Columbia University
Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW). The physiological consequences, i.e. changes in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (C-FOE) between ED and SCW ETT tracheal suctioning system in both open and closed catheter system settings will be evaluated using a randomized cross over design in preterm and term infants receiving mechanical ventilation via an ETT. This study will evaluate the hypothesis that there will be significantly lower variations in HR, SpO2, C-rSO2, and C-FOE during ETT suctioning with ED compared to SCW suctioning systems under both open and close ETT suction settings.
This description comes directly from the study's public registry record.
Rakesh Sahni, MD · 212-305-9743 · rs62@cumc.columbia.edu
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| Columbia University Irving Medical Center | New York, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06443970