Comparing two suction methods for intubated infants
Physiological Consequences of Low and High Flow Endotracheal Suctioning Devices in Intubated Preterm and Term Infants
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 28 Days |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06443970 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include preterm and term infants weighing more than 1000g who require endotracheal tube suctioning.
Not a fit: Patients with cyanotic congenital heart disease or cardiac rhythm disorders will not benefit from this study.
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 performed: While suctioning techniques have been studied, the specific comparison of the EXSALTA device to conventional suctioning in this population is novel.
Eligibility criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.