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NCT03691181 · ClinicalTrials.gov registry record · NA
Home COPD and Open Ventilation Evaluation (HOPE) Study
A NA study of Pulmonary Disease, Chronic Obstructive, sponsored by Landon Pediatric Foundation.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT03691181: Completed NA study of Pulmonary Disease, Chronic Obstructive, sponsored by Landon Pediatric Foundation.
NCT03691181 is a NA study of Pulmonary Disease, Chronic Obstructive that has completed, run by Landon Pediatric Foundation. The registered enrollment target is 6 participants, below the 1,044-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03691181, a NA study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Landon Pediatric Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
Respiratory related diseases such as chronic obstructive pulmonary disease (COPD) and neuromuscular diseases remain a major public health issue affecting millions of people worldwide. More than 15 million people are estimated to be diagnosed with COPD in the US alone. In the US, the direct and indirect costs associated with COPD are estimated to be about $50 billion. Clinical studies have shown that by providing ventilation to reduce respiratory insufficiency symptoms such as dyspnea, patients may become more tolerant to exercise and be able to increase their participation in activities of daily living resulting in an overall positive impact in their quality of lives. The Life2000 Ventilation System, with the smallest tubing and comfortable interface solutions, is the only ventilator to simultaneously provide full ventilatory support and enable patients to ambulate. The Life2000 Ventilation System is an FDA-cleared critical care ventilator (K141943/S003, June 2015) indicated for use for adult patients who require positive pressure ventilation delivered invasively or non-invasively. The device, classified by FDA as a continuous ventilator, can treat both acute and chronic respiratory failure and is suitable for use in home and institutional settings by qualified, trained personnel under the direction of a physician. The Life2000 Compressor is intended to provide a 50-psi pressure source to the ventilator and is currently in the FDA premarket notification (510 k) clearance process, so its use is considered investigational.
Primary Outcome
Score can range from 0 to 10. Higher score is associated with increased survival. B - Body Mass Index Values 0 points for a BMI greater than 21 1 point for a BMI less than 21 O - Airway Obstruction Values 0 points for an FEV1 greater than 64% 1 point for an FEV1 of 50-64% 2 points for an FEV1 of 36-49% 3 points for an FEV1 of less than 36% D - Dyspnea Values 0 points for a dyspnea index of 0-1 1. point for a dyspnea index of 2 2. points for a dyspnea index of 3 3. points for a dyspnea index o
Conditions Studied
Interventions
- DEVICE Ventilation
Study Locations (1)
California
- VCMC - Ventura
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-06 |
| Phase | NA |
What the finished NCT03691181 record still lists
NCT03691181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,044-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 1 intervention - of which Ventilation is the first listed.
NCT03691181 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03691181 about?
NCT03691181 is a clinical study titled "Home COPD and Open Ventilation Evaluation (HOPE) Study". Respiratory related diseases such as chronic obstructive pulmonary disease (COPD) and neuromuscular diseases remain a major public health issue affecting millions of people worldwide. More than 15 million people are estimated to be diagnosed with COPD in the US alone. In the US, the direct and indir...
What is the current status of trial NCT03691181?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2017-01. Estimated completion is 2018-06.
What conditions does trial NCT03691181 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT03691181?
The interventions under investigation include: Ventilation (DEVICE).
Who is sponsoring clinical trial NCT03691181?
This trial is sponsored by Landon Pediatric Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03691181 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03691181's enrollment target sits among peer trials
6 74th of 74 higher than 1 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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