Noninvasive Examination of the Work of Breathing in Patients With Amyotrophic Lateral Sclerosis (ALS).

This study has been terminated.
(Terminated due to difficulty enrolling subjects.)
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00718003
First received: July 14, 2008
Last updated: March 1, 2013
Last verified: March 2013

July 14, 2008
March 1, 2013
May 2005
February 2013   (final data collection date for primary outcome measure)
Calories Used with and without NIPPV [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT00718003 on ClinicalTrials.gov Archive Site
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Noninvasive Examination of the Work of Breathing in Patients With Amyotrophic Lateral Sclerosis (ALS).
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 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.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

ALS clinic patients at MDA/ALS Center of Hope.

  • Amyotrophic Lateral Sclerosis
  • Neurodegenerative Disease
  • Motor Neuron Disease
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ALS
Subjects having either definite or probable ALS by El Escorial Criteria.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with probable or definite ALS by El Escorial Criteria between ages 20-85 will be included for evaluation. They must have progression of disease over the preceding 6 months and duration of disease less then 5 years.

Exclusion Criteria:

  • Patients who do not meet clinical criteria of the diagnosis including those with pure upper motor neuron syndromes (PLS) or pure lower motor syndromes (SMA, Multifocal conduction block, motor neuropathies).
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00718003
Internal-15860
No
Drexel University ( Drexel University College of Medicine )
Drexel University College of Medicine
MDA/ALS Center of Hope
Principal Investigator: Terry Heiman-Patterson, MD Drexel University College of Medicine
Drexel University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP