RecruitingNot Applicable

Low and High Flow Suctioning in Intubated Infants

United States30 participantsStarted 2024-09-04

Plain-language 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.

Who can participate

Age range

28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in heart rate (HR)

Timeframe: Before suctioning (baseline) and up to 1-hour after suctioning

Change in oxygen saturation (SpO2)

Timeframe: Before suctioning (baseline) and up to 1-hour after suctioning

Change in cerebral oxygenation (C-rSO2)

Timeframe: Before suctioning (baseline) and up to 1-hour after suctioning

Change in cerebral fractional oxygen extraction (c-FOE)

Timeframe: Before suctioning (baseline) and up to 1-hour after suctioning

Trial details

NCT IDNCT06443970

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Rakesh Sahni, MD

212-305-9743 rs62@cumc.columbia.edu

View on ClinicalTrials.gov More Respiratory Failure trials

Plain-language summary

Who can participate

Age range

28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in heart rate (HR)

Timeframe: Before suctioning (baseline) and up to 1-hour after suctioning

Change in oxygen saturation (SpO2)

Timeframe: Before suctioning (baseline) and up to 1-hour after suctioning

Change in cerebral oxygenation (C-rSO2)

Timeframe: Before suctioning (baseline) and up to 1-hour after suctioning

Change in cerebral fractional oxygen extraction (c-FOE)

Timeframe: Before suctioning (baseline) and up to 1-hour after suctioning