Suction Devices for Respiratory Failure in Infants

Overseen By Rakesh Sahni, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Cyanotic heart disease, Arrythmias

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the Exsalta Suction Device safe for infants?

A study on endotracheal tube suction in a pediatric intensive care unit found that suction-related adverse events (unwanted side effects) can occur, but it did not specifically evaluate the Exsalta Suction Device. This suggests that while suction devices can have risks, specific safety data for the Exsalta Suction Device in infants is not available from the provided research. ^{1 2 3 4 5}

How does the Exsalta Suction Device treatment differ from other treatments 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 traditional methods. This device allows for a quicker recovery to normal oxygen levels, reducing the risk of complications in infants. ^{6 7 8 9 10}

Research Team

Rakesh Sahni, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

My baby was born weighing more than 1000g and needs suctioning.

Exclusion Criteria

My infant has a heart condition present from birth that causes bluish skin.

My infant has a heart rhythm problem.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two sequential suctioning procedures using EXSALTA and standard conventional wall suction devices

1 day

1 visit (in-person)

Follow-up

Participants are monitored for physiological changes such as heart rate, oxygen saturation, and cerebral oxygenation after suctioning

1 hour

Treatment Details

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.

Participant Groups

Group I: Exsalta Device suctioning Experimental Treatment 1 Intervention

Group II: Coventional wall suctioning Active Control 1 Intervention

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

References

1. China pubmed.ncbi.nlm.nih.gov

[Risk factors for the failure of the InSure method in very preterm infants with respiratory distress syndrome]. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Incidence, Outcome and Determinants of Unplanned Extubation Among Pediatric Intensive Care Unit Addis Ababa, Ethiopia, 2023: Nested, Unmatched Case-Control Study Design. [2023]

3. Australia pubmed.ncbi.nlm.nih.gov

Adverse events and practice variability associated with paediatric endotracheal suction: An observational study. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Risk factors for INSURE failure in preterm infants. [2013]

5. Australia pubmed.ncbi.nlm.nih.gov

Predictors and outcomes of extubation failure in extremely preterm infants. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Removing meconium from infant tracheae. What works best? [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

Safety of use, efficacy and degree of parental satisfaction with the nasal aspirator Narhinel in the treatment of nasal congestion in babies. [2014]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Closed versus open endotracheal suctioning in extremely low-birth-weight neonates: a randomized, crossover trial. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Prevention of hypoxia and hyperoxia during endotracheal suctioning. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A comparison of two airway suctioning frequencies in mechanically ventilated, very-low-birthweight infants. [2022]