Recruiting

Suctioning

Sponsor:

Columbia University

Code:

NCT06443970

Conditions

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Exsalta Suction Device

Study Details

Brief 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.

Conditions

Respiratory Failure

Study ID

NCT06443970

Start date

Sep 4, 2024

Status verified date

Apr, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exsalta Device suctioning

active comparator: Coventional wall suctioning

Interventions

Exsalta Suction Device

Low flow endotracheal suction device

Primary outcome measure

  • Change in heart rate (HR) [ Time Frame: Before suctioning (baseline) and up to 1-hour after suctioning ]
  • Change in oxygen saturation (SpO2) [ Time Frame: Before suctioning (baseline) and up to 1-hour after suctioning ]
  • Change in cerebral oxygenation (C-rSO2) [ Time Frame: Before suctioning (baseline) and up to 1-hour after suctioning ]
  • Change in cerebral fractional oxygen extraction (c-FOE) [ Time Frame: Before suctioning (baseline) and up to 1-hour after suctioning ]

Central Contacts and Locations

Central contacts

Rakesh Sahni, MD

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

Locations

Columbia University Irving Medical Center

Recruiting

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

Contacts

Rakesh Sahni, MD

2123059743rs62@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • cardiorespiratory disturbances
  • neonates
  • EXSALTA
  • Endotracheal Suctioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-13.