Low and High Flow Suctioning in Intubated Infants

Physiological Consequences of Low and High Flow Endotracheal Suctioning Devices in Intubated Preterm and Term Infants

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: Exsalta Suction Device

Detailed Description

Respiratory failure in neonates frequently requires mechanical ventilation through an endotracheal tube (ETT). The presence of an ETT inhibits the infant's intrinsic ability to clear endogenous lung secretions effectively with compromised glottic closure and impaired muccociliary function, and thus regular supportive suctioning of the ETT is essential. The benefits of patent airway are evident, but adverse effects may also result from suctioning which are especially deleterious in extremely preterm infants with immature pulmonary and systemic hemodynamic function. These adverse effects include transient hypoxemia and oxygen desaturation, vasovagal reactions, altered central and cerebral hemodynamics, atelectasis, pneumothorax, and mucosal damage. The cardiorespiratory instability during ETT suctioning is partially attributed to alveolar decruitment and loss of lung volume from disconnecting the ETT from the ventilator circuit and negative suction pressure. Maintenance of lung volume is essential to optimize gas exchange and prevent ventilator induced lung injury. The magnitude of lung volume loss is related to catheter size and applied suctioning pressure and flow, highlighting the complexity of interaction between suction technique, lung mechanics and disease state. In accordance with industry standard codes, a high flow rate is essential to ensure the rapid removal of fluid and secretions from the desired site and the standard conventional wall (SCW) suction outlets provide a minimum flow of approximately 85 liters per minute. Such high flows can lead to endotracheal suctioning-induced alveolar decruitment that may of significant clinical relevance. Recently, a low flow technology suction device EXSALTA (ED) for clearing ETT secretions in patients on ventilators has been approved by FDA. The device uses peristaltic action to move fluids from the patient to a collection canister at a fixed flow rate of 1.4 L/min and eliminates the uncontrolled flow of air from the patient's lungs. The user selects a desired pressure level that is independent of the flow rate, a feature unavailable with SCW wall suction equipment used at patient's bedside. This exceptional microprocessor-controlled tabletop suction device, available at any suction setting, reduces risk of negative pressures in the lungs to help prevent alveolar collapse and hypoxia associated with standard suctioning techniques. This study will examine the hypothesis that there will be significantly lower variations in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (c-FOE) with ED compared to SCW suction system during open or closed ETT suctioning. To test this hypothesis, the physiological consequences of two ETT suctioning systems in preterm and term infants will be evaluated using the following aims:

AIM 1. To compare the variations in HR (bpm), SpO2 (%), C-rSO2 (%), C-FOE (%) between ED and SCW suctioning systems during routine standard care open and closed ETT suctioning.

AIM II. To compare the incidence (episodes) of cardiorespiratory disturbances, i.e. bradycardia (HR<80 bpm) and/or hemoglobin oxygen desaturation (SpO2) < 80% for more than 10s during suctioning with ED and SCW suctioning system during routine standard care open and closed ETT suctioning.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rakesh Sahni, MD; Phone Number: 212-305-9743; Email: rs62@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032-3720
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Rakesh Sahni, MD; Phone Number: 2123059743; Email: rs62@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exsalta Device suctioning	Device: Exsalta Suction Device; Low flow endotracheal suction device
Active Comparator: Coventional wall suctioning	Device: Exsalta Suction Device; Low flow endotracheal suction device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bradycardia	Count (episodes) of HR<80% for more than 10 sec	Before suctioning (baseline) and up to 1-hour after suctioning
Incidence of hemoglobin oxygen desaturation	Count (episodes) of SpO2<80% for more than 10 sec	Before suctioning (baseline) and up to 1-hour after suctioning

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Rakesh Sahni, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: neonates; Endotracheal Suctioning; cardiorespiratory disturbances; EXSALTA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: AAAU9006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes