Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

• ClinicalTrials.gov Identifier: NCT00537446
• Recruitment Status: Terminated
• First Posted: October 1, 2007
• Results First Posted: November 27, 2020
• Last Update Posted: November 27, 2020
• Sponsor: Columbia University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	High Level and Low Level Ventilation
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

Baseline Characteristics

Arm/Group Title		High Level and Low Level Ventilation
Arm/Group Description		All participants
Overall Number of Baseline Participants		8
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

Outcome Measures

1. Primary Outcome

Title	Difference in Pulmonary Function and Respiratory Muscle Pressure Testing
Description	[Not Specified]
Time Frame	5 hours

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	5 hours

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	5 hours

Outcome Measure Data

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
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.

Adverse Events

Time Frame	5 hours
Adverse Event Reporting Description	No adverse events were observed.
Arm/Group Title	High-level Ventilation	Low-level Ventilation
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%)
Serious Adverse Events
	High-level Ventilation	Low-level Ventilation
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/8 (0.00%)	0/8 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Robert Basner, MD
• Organization: Columbia University Irving Medical Center
• EMail: rcb42@cumc.columbia.edu

• 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