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Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT00537446
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : October 1, 2007
Results First Posted : November 27, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Robert C. Basner, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Conditions Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Intervention Device: noninvasive positive pressure ventilation
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Level and Low Level Ventilation
Hide Arm/Group Description All participants are listed as one group, as the breakdown per Arm/Group is not available (PI no longer has raw data on file).
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title High Level and Low Level Ventilation
Hide Arm/Group Description All participants
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  87.5%
>=65 years
1
  12.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
1
  12.5%
Not Hispanic or Latino
7
  87.5%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Difference in Pulmonary Function and Respiratory Muscle Pressure Testing
Hide Description [Not Specified]
Time Frame 5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data were collected but not analyzed as specified in the title because the sample size does not generate enough statistical significance. PI no longer has raw data on file. All efforts have been made to retrieve the data and data could not be recovered.
Arm/Group Title High-level Ventilation Low-level Ventilation
Hide Arm/Group Description:

Each subject will spend 2 hours receiving high-level noninvasive ventilation.

noninvasive positive pressure ventilation: Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O.

Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.

noninvasive positive pressure ventilation: Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Difference in Gas Exchange
Hide Description [Not Specified]
Time Frame 5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data were collected but not analyzed as specified in the title because the sample size does not generate enough statistical significance. PI no longer has raw data on file. All efforts have been made to retrieve the data and data could not be recovered.
Arm/Group Title High-level Ventilation Low-level Ventilation
Hide Arm/Group Description:

Each subject will spend 2 hours receiving high-level noninvasive ventilation.

noninvasive positive pressure ventilation: Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O.

Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.

noninvasive positive pressure ventilation: Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Difference in Subjective Dyspnea Between Baseline and the Two Different Ventilator Modes
Hide Description [Not Specified]
Time Frame 5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data were collected but not analyzed as specified in the title because the sample size does not generate enough statistical significance. PI no longer has raw data on file. All efforts have been made to retrieve the data and data could not be recovered.
Arm/Group Title High-level Ventilation Low-level Ventilation
Hide Arm/Group Description:

Each subject will spend 2 hours receiving high-level noninvasive ventilation.

noninvasive positive pressure ventilation: Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O.

Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.

noninvasive positive pressure ventilation: Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 5 hours
Adverse Event Reporting Description No adverse events were observed.
 
Arm/Group Title High-level Ventilation Low-level Ventilation
Hide Arm/Group Description

Each subject will spend 2 hours receiving high-level noninvasive ventilation.

noninvasive positive pressure ventilation: Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O.

Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.

noninvasive positive pressure ventilation: Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O.

All-Cause Mortality
High-level Ventilation Low-level Ventilation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
High-level Ventilation Low-level Ventilation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High-level Ventilation Low-level Ventilation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Basner, MD
Organization: Columbia University Irving Medical Center
EMail: rcb42@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Robert C. Basner, Columbia University
ClinicalTrials.gov Identifier: NCT00537446    
Other Study ID Numbers: AAAC7394
First Submitted: September 27, 2007
First Posted: October 1, 2007
Results First Submitted: September 16, 2020
Results First Posted: November 27, 2020
Last Update Posted: November 27, 2020