Low and High Flow Suctioning in Intubated Infants

NCT06443970 | Recruiting DMC FDA Device

• 1 other identifier: AAAU9006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

cardiorespiratory disturbances; neonates; EXSALTA; Endotracheal Suctioning

Outcome Measures

Primary Outcomes (4)

• Change in heart rate (HR)

  Measured as beats per minute

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

• Change in oxygen saturation (SpO2)

  Measured as percent (%) change

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

• Change in cerebral oxygenation (C-rSO2)

  Measured as percent (%) change

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

• Change in cerebral fractional oxygen extraction (c-FOE)

  Measured as difference in SpO2 and C-rSO2 (%)

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

Secondary Outcomes (2)

• Incidence of bradycardia

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

• Incidence of hemoglobin oxygen desaturation

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

Study Arms (2)

Exsalta Device suctioning

EXPERIMENTAL

Device: Exsalta Suction Device

Coventional wall suctioning

ACTIVE COMPARATOR

Device: Exsalta Suction Device

Interventions

Exsalta Suction Device DEVICE

Low flow endotracheal suction device

Coventional wall suctioning; Exsalta Device suctioning

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm and term infants with birth weight more than 1000g receiving ETT suctioning

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

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

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Rakesh Sahni, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rakesh Sahni, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: In each group of study infants (open and closed ETT suctioning), the enrolled subjects will experience ETT suctioning with both methods, i.e. with ED and SCW suctioning systems. Each study infant will undergo two sequential suctioning procedures each day during the two-day study period. On day-1, the infant will be randomly assigned the ED or SCW suctioning device during the first maneuver and the devices will be alternated during the second maneuver. The suctioning device order will be reversed on study day-2 as shown in the study protocol below. In all each infant will have four suctioning maneuvers over two days, two each with ED and SCW suctioning devices.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 5, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)