Low and High Flow Suctioning in Intubated Infants
ConditionRespiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 28
SponsorColumbia University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm and term infants with birth weight more than 1000g receiving ETT suctioning
Disqualifiers
Infants with cyanotic congenital heart disease and cardiac rhythm disorders (arrythmias) will be excluded from the study.
Trial design
Design model
Crossover
Treatments tested in this trial
Exsalta Suction Device
DeviceLow flow endotracheal suction device
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Exsalta Device suctioningExperimental treatment 1 intervention
Group B: Coventional wall suctioningActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in heart rate (HR)
Measured as beats per minute
Time frame
Before suctioning (baseline) and up to 1-hour after suctioning2
Change in oxygen saturation (SpO2)
Measured as percent (%) change
Time frame
Before suctioning (baseline) and up to 1-hour after suctioning3
Change in cerebral oxygenation (C-rSO2)
Measured as percent (%) change
Time frame
Before suctioning (baseline) and up to 1-hour after suctioning4
Change in cerebral fractional oxygen extraction (c-FOE)
Measured as difference in SpO2 and C-rSO2 (%)
Time frame
Before suctioning (baseline) and up to 1-hour after suctioningSecondary outcomes
1
Incidence of bradycardia
Count (episodes) of HR\<80% for more than 10 sec
Time frame
Before suctioning (baseline) and up to 1-hour after suctioning2
Incidence of hemoglobin oxygen desaturation
Count (episodes) of SpO2\<80% for more than 10 sec
Time frame
Before suctioning (baseline) and up to 1-hour after suctioningSponsors and contacts
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Source ClinicalTrials.gov