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

NCT03473171 | Terminated Results FDA Device

• 1 other identifier: HSC-MS-17-0708
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Respiratory Failure

Keywords

nasal non-invasive ventilation; RAM Cannula; Pediatric Complex Care; Tracheostomy Avoidance

Outcome Measures

Primary Outcomes (1)

• Feasibility as Assessed by Number of Participants Who Had Complications

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

  7 days after starting the RAM cannula

Study Arms (1)

Nasal non-invasive ventilation with RAM cannula

EXPERIMENTAL

Device: Nasal non-invasive ventilation with RAM cannula

Interventions

Nasal non-invasive ventilation with RAM cannula DEVICE

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.

Nasal non-invasive ventilation with RAM cannula

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: James M. Stark, MD
• Organization: The University of Texas Health Science Center at Houston

James.M.Stark@uth.tmc.edu

713-500-5650

Study Officials

• Wilfredo De Jesus Rojas, MD, FAAP

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 22, 2018
• Study Start: June 27, 2016
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Locations

US (1)