Low and High Flow Suctioning in Intubated Infants

NCT ID: NCT06443970

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-04
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Respiratory Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exsalta Device suctioning

Group Type: EXPERIMENTAL

Exsalta Suction Device

Intervention Type: DEVICE

Low flow endotracheal suction device

Coventional wall suctioning

Group Type: ACTIVE_COMPARATOR

Exsalta Suction Device

Intervention Type: DEVICE

Low flow endotracheal suction device

Interventions

Exsalta Suction Device

Low flow endotracheal suction device

Intervention Type: DEVICE

Eligibility Criteria

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.

• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Rakesh Sahni

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rakesh Sahni, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rakesh Sahni, MD

Role: CONTACT

rs62@cumc.columbia.edu

212-305-9743

Facility Contacts

Rakesh Sahni

Role: primary

rs62@cumc.columbia.edu

212-305-9743

Other Identifiers

AAAU9006

Identifier Type: -

Identifier Source: org_study_id