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Clinical Trials/NCT03473171
NCT03473171
Terminated
Not Applicable

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

The University of Texas Health Science Center, Houston1 site in 1 country5 target enrollmentJune 27, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Respiratory Failure
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
5
Locations
1
Primary Endpoint
Feasibility as Assessed by Number of Participants Who Had Complications
Status
Terminated
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 27, 2016
End Date
May 13, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

James M. Stark

Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • Children admitted to the Children Memorial Hermann Hospital and consulted to Pediatric Pulmonary Service for initiation of NIV/RAM-NC both at the inpatient and outpatient sites.
  • Children who fail to wean from chronic respiratory support (CPAP, BiPAP, HFNC) in whom long-term ventilation is considered between 10/2016 - 10/2017 will be included.

Exclusion Criteria

  • Children with minimal setting (CPAP \< 5cmH2O, HFNC \< 3LPM) able to be weaned to regular nasal cannula.
  • Patients with upper airway obstruction that may be candidates for surgical procedure will be excluded.

Outcomes

Primary Outcomes

Feasibility as Assessed by Number of Participants Who Had Complications

Time Frame: 7 days after starting the RAM cannula

Complications include respiratory failure, tachypnea, hypercapnia, hypoxemia, air trapping or hyperexpansion.

Study Sites (1)

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