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NCT00718003 · ClinicalTrials.gov registry record
Noninvasive Examination of the Work of Breathing in Patients With Amyotrophic Lateral Sclerosis (ALS).
A clinical trial, sponsored by Drexel University College of Medicine.
- Terminated
- Registry status
- 10
- Enrollment target
NCT00718003: Clinical Trial study, sponsored by Drexel University College of Medicine.
NCT00718003 is a clinical trial that was terminated before completion, run by Drexel University College of Medicine. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00718003 was terminated before completion, sponsored by Drexel University College of Medicine.
- TERMINATED
- Registry status
- 10 participants
- Enrollment target
Study Summary
The literature to date indicates that noninvasive positive pressure ventilation (NIPPV) provides effective noninvasive ventilator support, prolongs survival, and improves quality of life (QOL) in Amyotrophic Lateral Sclerosis (ALS) patients. It is generally recommended to patients when their pulmonary function testing demonstrates a drop to 50% forced vital capacity (FVC). One result of using NIPPV may be a reduction in the work of the breathing which would lead to decreased caloric needs. However, the work of breathing and the effects of noninvasive ventilation on caloric use have not been studied in patients with ALS. This is extremely important since there may be a reduction in the caloric needs when ALS patients are placed on NIPPV and if the caloric intake is not adjusted, overfeeding can occur. Overfeeding with too many calories can lead to an increase in carbon dioxide which would actually worsen the respiratory failure. The overall aim of this project is to evaluate how many calories are used by ALS patients while at rest, when placed on NIPPV, and when breathing against a resistance. This will be accomplished using a metabolic cart during these activities. At present, the metabolic cart is routinely used in ALS patients at the time of feeding tube placement to calculate caloric needs. Using the cart to calculate the caloric expenditure on and off the ventilator will aid in calculating the work of breathing and the effects of NIPPV on work of breathing.
Primary Outcome
Indirect calorimetry will be performed using a metabolic cart to determine caloric use over a 20 minute period without NIPPV. Following this, the test will be repeated over a 20 minute period with NIPPV.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2005-05 |
| Est. Completion | 2013-02 |
Why NCT00718003 stopped before completion
NCT00718003 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00718003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00718003 about?
NCT00718003 is a clinical study titled "Noninvasive Examination of the Work of Breathing in Patients With Amyotrophic Lateral Sclerosis (ALS).". The literature to date indicates that noninvasive positive pressure ventilation (NIPPV) provides effective noninvasive ventilator support, prolongs survival, and improves quality of life (QOL) in Amyotrophic Lateral Sclerosis (ALS) patients. It is generally recommended to patients when their pulmona...
What is the current status of trial NCT00718003?
This trial is currently terminated. The enrollment target is 10 participants. The study started on 2005-05. Estimated completion is 2013-02.
Who is sponsoring clinical trial NCT00718003?
This trial is sponsored by Drexel University College of Medicine, which has 25 total clinical trials registered on ClinicalTrials.gov.
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