Comparing two suction methods for intubated infants
Official title: Physiological Consequences of Low and High Flow Endotracheal Suctioning Devices in Intubated Preterm and Term Infants
Run by Columbia University · NCT06443970 · Data updated 2026-11-12
This study is testing whether a new suction device is better for preterm and term infants on breathing machines than the standard suction method by looking at how it affects their heart rate and oxygen levels.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 28 Days |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | September 4, 2024 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT06443970 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include preterm and term infants weighing more than 1000g who require endotracheal tube suctioning.
✕Probably not a fit
Patients with cyanotic congenital heart disease or cardiac rhythm disorders will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the physiological effects of two suctioning techniques, the new EXSALTA suction device and the standard conventional wall suction, on preterm and term infants in the NICU who are receiving mechanical ventilation. Using a randomized crossover design, the study will measure changes in heart rate, oxygen saturation, cerebral oxygenation, and cerebral fractional oxygen extraction during suctioning procedures. The goal is to determine if the EXSALTA device results in less physiological disturbance compared to the conventional method. This research aims to improve suctioning practices for neonates with respiratory failure.
Why it matters
Potential benefit: If successful, this study could lead to safer suctioning techniques that minimize cardiorespiratory disturbances in intubated infants.
How similar studies have gone: While suctioning techniques have been studied, the specific comparison of the EXSALTA device to conventional suctioning in this population is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm and term infants with birth weight more than 1000g receiving ETT suctioning Exclusion Criteria: * Infants with cyanotic congenital heart disease and cardiac rhythm disorders (arrythmias) will be excluded from the study.
Where it's running
-
Columbia University Irving Medical Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Rakesh Sahni, MD — Columbia University
- Study coordinator: Rakesh Sahni, MD
- Email: rs62@cumc.columbia.edu
- Phone: 212-305-9743
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.