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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03473171
Other study ID # HSC-MS-17-0708
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 27, 2016
Est. completion date May 13, 2019

Study information

Verified date March 2020
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date May 13, 2019
Est. primary completion date May 13, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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