N/A N=28 Randomized Single-blind Treatment

Study of Standard Noninvasive Positive Pressure Ventilation (NIPPV) and Low Expiratory Pressure NIPPV in ALS Patients

Amyotrophic Lateral Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT01154283 ↗

Enrolled (actual)

Serious AEs

7.1%

Results posted

Jan 2017

Primary outcome: Primary: Hours of NIPPV Usage — 49.94; 45.75 hours

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine) (Device)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Kirsten Gruis
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Hours of NIPPV Usage	49.94; 45.75	—
SECONDARY Patient Preference (Likert Scale) "Definitely IPAP-only" "Probably IPAP-only" "Uncertain" "Probably Bi-level" "Definitely Bi-level"	2; 12	—
SECONDARY Transitional Dyspnea Index	-3.14; -1.21	—
SECONDARY EuroQol Visual Analogue Scale(VAS)	52.86; 62.79	—

Summary

The purpose of the study is to test whether noninvasive positive pressure ventilation (NIPPV) without expiratory positive airway pressure (EPAP) (inspiratory positive airway pressure (IPAP)-only) will result in an increase in patient usage of NIPPV compared with standard, Bi-level NIPPV. Secondarily, the investigators will assess measures of dyspnea, quality of life, patient satisfaction, and side effects.

Eligibility Criteria

Inclusion Criteria

Age greater than 18 years
Definite or probable ALS by El Escorial criteria
Maximal inspiratory force < 60 cm/H2O or FVC <50% predicted (American College of Chest Physicians' criteria for initiating NIPPV)
Patients must have used NIPPV (typically administered as BiPAP) for at least 2 months
Currently using NIPPV ≥5 days a week with an EPAP = 4 cm H2O.

Exclusion Criteria

Any medical condition that will interfere with participation
Inability to consent for him/herself
Known obstructive sleep apnea or obstructive pulmonary disease.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01154283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.