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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 is a NA study that was terminated before completion, run by San Francisco Veterans Affairs Medical Center. The registered enrollment target is 6 participants.
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
Interventions
- DEVICE Noninvasive Ventilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2024-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04413643
The ClinicalTrials.gov registry entry for NCT04413643 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is San Francisco Veterans Affairs Medical Center, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Noninvasive Ventilation is the first listed.
NCT04413643 reports 0 study locations.
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.
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