Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443970
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-13
Brief Title:
Low and High Flow Suctioning in Intubated Infants
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Physiological Consequences of Low and High Flow Endotracheal Suctioning Devices in Intubated Preterm and Term Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 infants 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 14 Lmin and eliminates the uncontrolled flow of air from the patients 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 patients 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 ie bradycardia HR80 bpm andor 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
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 ie bradycardia HR80 bpm andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None