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
  Purpose

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
Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Noninvasive Examination of the Work of Breathing in Patients With Amyotrophic Lateral Sclerosis (ALS).

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: May 2005
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
ALS
Subjects having either definite or probable ALS by El Escorial Criteria.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ALS clinic patients at MDA/ALS Center of Hope.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718003

Locations
United States, Pennsylvania
MDA/ALS Center of Hope
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Drexel University College of Medicine
MDA/ALS Center of Hope
Investigators
Principal Investigator: Terry Heiman-Patterson, MD Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier: NCT00718003     History of Changes
Other Study ID Numbers: Internal-15860
Study First Received: July 14, 2008
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Respiratory Aspiration
Sclerosis
Motor Neuron Disease
Neurodegenerative Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014