Physiological Consequences of Low and High Flow Endotracheal Suctioning Devices in Intubated Preterm and Term Infants

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 28 days
Healthy Volunteers: f
View:

• Preterm and term infants with birth weight more than 1000g receiving ETT suctioning

Locations
United States
New York
Columbia University
RECRUITING
New York
Contact Information
Primary
Rakesh Sahni, MD
rs62@cumc.columbia.edu
212-305-9743
Time Frame
Start Date: 2024-09-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Exsalta Device suctioning
Active_comparator: Coventional wall suctioning
Related Therapeutic Areas
Sponsors
Leads: Columbia University

This content was sourced from clinicaltrials.gov