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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor