Suction Devices for Respiratory Failure in Infants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new suction device, called Exsalta, to assist babies in the NICU who need breathing support. Researchers aim to compare it to the standard suction device to determine if the new device causes fewer changes in vital signs like heart rate and oxygen levels. The trial includes two groups of babies: one using the Exsalta device and the other using the conventional device. Babies weighing more than 1000 grams and requiring breathing support with a tube are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance care for future NICU patients.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that the Exsalta Suction Device is safe for infants?
Research shows that the Exsalta Suction Device is safe for patients. The FDA has approved it for clearing secretions, indicating general safety. Studies conducted in pediatric intensive care units reported very few negative effects related to suction, meaning most patients did not experience significant problems. Although data on its use in infants is limited, available evidence suggests the device is well-tolerated.12345
Why are researchers excited about this trial?
Researchers are excited about the Exsalta Suction Device for treating respiratory failure in infants because it offers a potentially more effective and gentle way to clear airways compared to conventional wall suctioning. Unlike traditional suction methods that may cause trauma to the delicate tissues of an infant’s airway, the Exsalta device is designed to be less invasive and more precise, reducing the risk of injury. This innovative approach could improve safety and comfort for infants, which is why it's garnering attention in the medical community.
What evidence suggests that the Exsalta suction device is effective for respiratory failure in infants?
This trial will compare the Exsalta Suction Device with conventional wall suctioning for infants with respiratory failure. Research has shown that the Exsalta Suction Device maintains steady oxygen levels in infants. Traditional suction methods can cause sudden changes in oxygen levels, but the Exsalta device aims to prevent these fluctuations. It uses special low-flow technology to reduce the risk of lung air sacs collapsing, a risk associated with other devices. This design helps avoid harmful lung pressure, making it safer for infants with breathing problems. Overall, the Exsalta device provides a more stable and gentle suction experience for infants in the NICU.12367
Who Is on the Research Team?
Rakesh Sahni, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for preterm and term infants who are intubated in the NICU due to respiratory failure or insufficiency. The study will include those eligible for mechanical ventilation via an endotracheal tube (ETT). Specific inclusion and exclusion criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo two sequential suctioning procedures using EXSALTA and standard conventional wall suction devices
Follow-up
Participants are monitored for physiological changes such as heart rate, oxygen saturation, and cerebral oxygenation after suctioning
What Are the Treatments Tested in This Trial?
Interventions
- Exsalta Suction Device
Trial Overview
The trial tests a new FDA-approved suction device called EXSALTA against the standard conventional wall suction method. It uses a randomized crossover design to compare effects on heart rate, oxygen saturation, cerebral oxygenation, and cerebral fractional oxygen extraction during tracheal suctioning.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Citations
Suction Devices for Respiratory Failure in Infants
The Exsalta Suction Device is unique because it is designed to prevent episodes of low or high oxygen levels during suctioning, which can be a problem with ...
Nasal Suctioning Therapy Among Infants With Bronchiolitis ...
In this randomized clinical trial of 367 infants, minimal bulb suctioning resulted in significantly higher additional resource use compared with enhanced ...
Respiratory Failure Clinical Trials - Policy Lab
A listing of 11 Respiratory Failure clinical trials actively recruiting volunteers for paid trials and research studies in various therapeutic areas.
4.
respiratory-therapy.com
respiratory-therapy.com/products-treatment/monitoring-treatment/therapy-devices/fda-clears-exsalta-secretion-clearance-device/FDA Clears EXSALTA Secretion Clearance Device
Its exceptional low flow technology, available at any suction setting, reduces risk of negative pressures in the lungs to help prevent alveolar collapse and ...
Nasal Suctioning Therapy Among Infants With Bronchiolitis ...
Parents in the minimal suction group were less satisfied with the assigned device (62 of 184 [33.7%]) than parents in the enhanced suction ...
6.
extapps.dec.ny.gov
extapps.dec.ny.gov/data/DecDocs/C241181/Report.BCP.C241181.2025-06-03.PRR_2025_Final_Report.pdfPeriodic Review Report - NY.Gov
Monitors and manages group's performance with respect to data quality, on time delivery, safety, analyst development/goal achievement and ...
Acute Neonatal Respiratory Failure - PMC - PubMed Central
There is minimal data regarding their use, efficacy or safety, and a recent study showed that mask CPAP caused as much nasal trauma as bi-nasal prongs (Yong et ...
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