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

March 16, 2020 updated by: James M. Stark, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nasal non-invasive ventilation with RAM cannula
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days after starting the RAM cannula

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Wilfredo De Jesus Rojas, MD, FAAP, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2016

Primary Completion (Actual)

May 13, 2019

Study Completion (Actual)

May 13, 2019

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-17-0708

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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