Noninvasive Examination of the Work of Breathing in Patients With Amyotrophic Lateral Sclerosis (ALS).
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00718003|
Recruitment Status : Terminated (Terminated due to difficulty enrolling subjects.)
First Posted : July 18, 2008
Last Update Posted : March 5, 2013
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.
|Condition or disease|
|Amyotrophic Lateral Sclerosis Neurodegenerative Disease Motor Neuron Disease|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Noninvasive Examination of the Work of Breathing in Patients With Amyotrophic Lateral Sclerosis (ALS).|
|Study Start Date :||May 2005|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
Subjects having either definite or probable ALS by El Escorial Criteria.
- Calories Used with and without NIPPV [ Time Frame: 20 minutes ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718003
|United States, Pennsylvania|
|MDA/ALS Center of Hope|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Terry Heiman-Patterson, MD||Drexel University College of Medicine|