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NCT04413643 · ClinicalTrials.gov registry record · NA
NIV for COPD: Hospital to Home
A NA study, sponsored by San Francisco Veterans Affairs Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT04413643: Clinical Trial NA study, sponsored by San Francisco Veterans Affairs Medical Center.
NCT04413643 is a NA study that was terminated before completion, run by San Francisco Veterans Affairs Medical Center. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04413643, a NA study, was terminated before completion, sponsored by San Francisco Veterans Affairs Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a pilot study to evaluate the impact of providing patients admitted with acute exacerbations of COPD (AECOPD) with non-invasive ventilation (NIV)home devices prior to discharge on hospital readmission rates and other secondary outcomes. Aim 1 To test whether continuation of NIV at home after being initiated during hospitalization for AECOPD improves subsequent admission-free survival in patients with chronic hypercapnic respiratory failure secondary to COPD Hypothesis 1: The use of targeted NIV during hospitalization with continuation upon discharge to home will improve one-year all-cause mortality as compared to published mortality in the current literature. Hypothesis 2: The use of targeted NIV during hospitalization with continuation upon discharge to home will reduce readmission rates for AECOPD within-institution historical data. Aim 2 To evaluate the feasibility of a larger multisite randomized controlled trial in veterans using inclusion and exclusion criteria specified in this pilot. Outcomes Primary: Event-free survival (re-hospitalization for AECOPD, time to readmission for AECOPD, and all-cause mortality) Secondary: 1. Unplanned readmission rates (all complications) 2. Time to readmissions for admissions other than AECOPD. 3. Arterial blood gas/Venous blood gas (ABG/VBG): PaO2, PaCO2 and serum bicarbonate at Baseline, 6 and 12 months 4. Pulmonary function (handheld spirometer or in-laboratory based on specific institution resources) at Baseline, 6, and 12 months 5.6 minute walk test at Baseline, 6,and 12 months 6.Health related quality of life (HRQOL) measured by the St. Georges respiratory questionnaires (SGRQ) at Baseline, 1,3,6,9 and 12 months 7.Adherence to NIV at Week 1-2, Months 1,3,6,9 and 12 8.Sleep assessed by type 3 portable monitors 9.Sleep assessed by questionnaires: Insomnia severity index (ISI), Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Functional Outcomes of Sleep Short Form (FOSQ-10) at Baselin
Primary Outcome
Re-hospitalization for AECOPD, time to readmission for AECOPD, and all-cause mortality
Interventions
- DEVICE Noninvasive Ventilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2024-04-01 |
| Phase | NA |
Why NCT04413643 stopped before completion
NCT04413643 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Noninvasive Ventilation is the first listed.
NCT04413643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04413643 about?
NCT04413643 is a clinical study titled "NIV for COPD: Hospital to Home". This is a pilot study to evaluate the impact of providing patients admitted with acute exacerbations of COPD (AECOPD) with non-invasive ventilation (NIV)home devices prior to discharge on hospital readmission rates and other secondary outcomes. Aim 1 To test whether continuation of NIV at home afte...
What is the current status of trial NCT04413643?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2019-05-09. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT04413643?
The interventions under investigation include: Noninvasive Ventilation (DEVICE).
Who is sponsoring clinical trial NCT04413643?
This trial is sponsored by San Francisco Veterans Affairs Medical Center, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04413643's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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