Low and High Flow Suctioning in Intubated Infants
This study is looking at how different suctioning methods affect intubated infants (babies with a breathing tube) who are in the Neonatal Intensive Care Unit (NICU) due to respiratory failure (trouble breathing). Researchers are comparing a new, FDA-approved device called EXSALTA with the standard suctioning method used in hospitals. They want to see how these methods change your baby's heart rate, oxygen levels in the blood (SpO2), and oxygen levels in the brain (C-rSO2) up to one hour after suctioning. The study is enrolling 30 infants. To join, your baby must be a preterm (born early) or full-term infant, weigh more than 1000 grams, and be receiving endotracheal tube (ETT) suctioning. Babies with certain heart conditions are not eligible. The study status is currently unclear.
- Study design
- This study is an interventional study with a planned enrollment of 30 infants. It uses a randomized crossover design, meaning each infant will experience both suctioning methods in a random order.
- What's involved
- Your baby will undergo two sequential suctioning procedures, one with the EXSALTA device and one with the standard conventional wall suction. Heart rate, oxygen saturation, and cerebral oxygenation will be measured before and up to one hour after each suctioning.
- Compensation
- Not stated in the trial record.
- Follow-up
- Measurements will be taken up to one hour after suctioning procedures.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Low and High Flow Suctioning in Intubated Infants
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rakesh Sahni, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in heart rate (HR)Before suctioning (baseline) and up to 1-hour after suctioning
Measured as beats per minute
- Change in oxygen saturation (SpO2)Before suctioning (baseline) and up to 1-hour after suctioning
Measured as percent (%) change
- Change in cerebral oxygenation (C-rSO2)Before suctioning (baseline) and up to 1-hour after suctioning
Measured as percent (%) change
- Change in cerebral fractional oxygen extraction (c-FOE)Before suctioning (baseline) and up to 1-hour after suctioning
Measured as difference in SpO2 and C-rSO2 (%)