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NCT02354651 · ClinicalTrials.gov registry record
Response to Diaphragmatic Pacing in Subjects With Pompe Disease
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 9
- Enrollment target
NCT02354651: Completed study, sponsored by University of Florida.
NCT02354651 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02354651 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 9 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effect of diaphragm pacing on respiratory function in subjects with Pompe disease by evaluating the duration and pattern of spontaneous respiratory function versus paced ventilation respiratory function in patients with Pompe disease who have received the NeuDx Diaphragm pacer (DPS).
Primary Outcome
The patient will undergo an initial trial of unassisted breathing with the diaphragm pacer turned on. The duration of SB with pacing will be increased to tolerance, using a protocol. If the patient cannot initially complete at least 30-minute bouts of paced SB, then the focus of breathing trials will be to breathe with reduced support from the mechanical ventilator. These measures were generated utilizing ventilator chip data for SB that has been averaged.
Interventions
- OTHER Diaphragm conditioning via phrenic nerve stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-05 |
| Est. Completion | 2023-01 |
What the finished NCT02354651 record still lists
NCT02354651 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 9 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Diaphragm conditioning via phrenic nerve stimulation is the first listed.
NCT02354651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02354651 about?
NCT02354651 is a clinical study titled "Response to Diaphragmatic Pacing in Subjects With Pompe Disease". The purpose of this study is to determine the effect of diaphragm pacing on respiratory function in subjects with Pompe disease by evaluating the duration and pattern of spontaneous respiratory function versus paced ventilation respiratory function in patients with Pompe disease who have received th...
What is the current status of trial NCT02354651?
This trial is currently completed. The enrollment target is 9 participants. The study started on 2013-05. Estimated completion is 2023-01.
What interventions are being tested in trial NCT02354651?
The interventions under investigation include: Diaphragm conditioning via phrenic nerve stimulation (OTHER).
Who is sponsoring clinical trial NCT02354651?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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