NCT03473171

Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 1 Day – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to implement a standardized protocol to initiate nasal non-invasive ventilation with RAM nasal cannula (NIV/RAM-NC) with Trilogy mechanical ventilator at Children Memorial Hospital inpatient and outpatient sites, as well as to explore the side effects and complications associated with the use of NIV/RAM-NC in children.

Conditions

• Chronic Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Nasal non-invasive ventilation with RAM cannula	Pediatric Pulmonary Team will be consulted on inpatient or outpatient patients that fail to wean from chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula) in whom long-term ventilation is considered. Pediatric Pulmonary Team, as a consultant, will consider patient history, physical examination, previous imaging and laboratories and previous attempts to wean from respiratory support and causes of failure to wean. The Pulmonary team will determine which patients would potentially benefit from use of NIV/RAM-NC for long-term respiratory support and will recommend initiation of NIV/RAM-NC.

Timeline

• Start date: 2016-06-27
• Primary completion: 2019-05-13
• Completion: 2019-05-13
• First posted: 2018-03-22
• Last updated: 2020-03-24
• Results posted: 2020-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study