Low and High Flow Suctioning in Intubated Infants

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06443970
Status
Recruiting
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Conditions

  • Respiratory Failure

Eligibility Criteria

Sex
ALL
Age
N/A - 28 Days
Healthy Volunteers
Not accepted

Interventions

  • Exsalta Suction Device — DEVICE
    Low flow endotracheal suction device

Study Details

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.

Key Dates

Start date
Sep 4, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Exsalta Device suctioning
  • Active Comparator: Coventional wall suctioning

Primary Outcome Measure

Change in heart rate (HR) [ Time Frame: Before suctioning (baseline) and up to 1-hour after suctioning ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032-3720
Rakesh Sahni, MD
[email protected]
2123059743

Find similar trials in New York, NY

By research site
Columbia University Irving Medical Center· New York, NY

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