Noninvasive Examination of the Work of Breathing in Patie... | NCT00718003

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

NCT00718003

Sponsor

Drexel University College of Medicine

Status

Terminated

Last Update Posted

Mar 5, 2013Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated due to difficulty enrolling subjects.

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 16, 2008

First Posted Date

Jul 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2013

Last Update Posted Date

Mar 5, 2013Estimated

Name	Class
MDA/ALS Center of Hope	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Conditions Module

Conditions

Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease

Keywords

Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALS		Subjects having either definite or probable ALS by El Escorial Criteria.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Calories Used with and without NIPPV	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.	20 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

ALS clinic patients at MDA/ALS Center of Hope.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Terry Heiman-Patterson, MD	Drexel University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MDA/ALS Center of Hope		Philadelphia	Pennsylvania	19104	United States

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis
D019636	Neurodegenerative Diseases
D016472	Motor Neuron Disease
D009069	Movement Disorders

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D057177	TDP-43 Proteinopathies

Browse Leaves

Not provided

Browse Branches

Not provided