Back to resultsImplementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting
Primary Purpose
Chronic Respiratory Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal non-invasive ventilation with RAM cannula
Sponsored by
About this trial
This is an interventional other trial for Chronic Respiratory Failure focused on measuring nasal non-invasive ventilation, RAM Cannula, Pediatric Complex Care, Tracheostomy Avoidance
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.
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nasal non-invasive ventilation with RAM cannula
Arm Description
Outcomes
Primary Outcome Measures
Feasibility as Assessed by Number of Participants Who Had Complications
Complications include respiratory failure, tachypnea, hypercapnia, hypoxemia, air trapping or hyperexpansion.
Secondary Outcome Measures
Full Information
NCT ID
NCT03473171
First Posted
March 14, 2018
Last Updated
March 16, 2020
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03473171
Brief Title
Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting
Official Title
Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
PI left the institution
Study Start Date
June 27, 2016 (Actual)
Primary Completion Date
May 13, 2019 (Actual)
Study Completion Date
May 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure
Keywords
nasal non-invasive ventilation, RAM Cannula, Pediatric Complex Care, Tracheostomy Avoidance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal non-invasive ventilation with RAM cannula
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Nasal non-invasive ventilation with RAM cannula
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility as Assessed by Number of Participants Who Had Complications
Description
Complications include respiratory failure, tachypnea, hypercapnia, hypoxemia, air trapping or hyperexpansion.
Time Frame
7 days after starting the RAM cannula
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfredo De Jesus Rojas, MD, FAAP
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting
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