Actively Recruiting

Phase Not Applicable
Age: 0 - 28Days
All Genders
NCT06443970

Low and High Flow Suctioning in Intubated Infants

Led by Columbia University · Updated on 2026-04-13

30

Participants Needed

1

Research Sites

121 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Low and High Flow Suctioning in Intubated Infants

Who Can Participate

Age: 0 - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm and term infants with birth weight more than 1000g receiving ETT suctioning
Not Eligible

You will not qualify if you...

  • Infants with cyanotic congenital heart disease and cardiac rhythm disorders (arrythmias) will be excluded from the study.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center

New York, New York, United States, 10032-3720

Actively Recruiting

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Research Team

R

Rakesh Sahni, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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