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Impact of Early Non Invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Patients

This study is currently recruiting participants.
Verified July 2012 by Hospital Universitari de Bellvitge
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Eva Farrero Munoz, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01641965
First received: July 13, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes

July 13, 2012
July 19, 2012
April 2012
April 2015   (final data collection date for primary outcome measure)
survival until death or tracheostomy [ Time Frame: three years ] [ Designated as safety issue: No ]
To evaluate the impact of the early use of NIV in the survival function of the time until death or tracheostomy of ALS patients, compared with a standard initiation of NIV.
Same as current
Complete list of historical versions of study NCT01641965 on ClinicalTrials.gov Archive Site
effects from early use of NIV in progression of respiratory muscle weakness [ Time Frame: three years ] [ Designated as safety issue: No ]
To determine the effects from early use of NIV in progression of respiratory muscle weakness, measured by rate of decline in FVC
Same as current
Not Provided
Not Provided
 
Impact of Early Non Invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Patients
Impact of Early Non-invasive Ventilation in Amyotrophic Lateral Sclerosis Patients: a Randomized Controlled Trial

Timing of initiating domiciliary no invasive ventilation (NIV) in amyotrophic lateral sclerosis patients remains unclear. The hypothesis of the study is that the early use of NIV, in the initial phase of respiratory muscle weakness, improves the prognosis of ALS patients.

Principal objective: To evaluate the impact of early NIV in the survival of ALS patients.

Secondary objectives:To determine the effects from early NIV in the progression of respiratory muscle weakness. To analyze the impact of early NIV in the quality of life of ALS patients. To evaluate the correlation between the FVC and other parameters of respiratory evaluation (maximal inspiratory pressure (MIP), sniff nasal inspiratory pressure (SNP), nocturnal desaturation) and their utility in the early indication of the NIV. To evaluate the tolerance to the early NIV.

Methods: multicentric, randomized, open-label, controlled clinical trial with a parallel treatment design. Patients will be included when their FVC reaches the threshold of the 75% of the predicted value and will be randomized in: Group A: the NIV treatment will begin immediately and Group B: the NIV treatment will be started when patients fulfil at least one of the following criteria: (i) FVC < 50% predicted, (ii) orthopnea, and/or (iii) PaCO2 > 45 mmHg. Follow-up visits will be done every three months with pulmonary function test, nocturnal pulse oximetry, quality of life and quality of sleep tests, assessment of disease progression (ALSFSR-R scale), tolerance and compliance with NIV.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
Device: Home pressure ventilator model Vivo 40 (BREAS Medical AB)
Nocturnal non invasive ventilation (Vivo 40)with minimum pressure support of 10 cm H2O (IPAP 14, EPAP 4). Parameters will be adjusted according to tolerance and to achieve PaCO2 < 45 mmHg and improve symptoms.
  • Active Comparator: early non invasive ventilation
    Patients assigned to this arm will start non invasive ventilation with home pressure ventilator model Vivo 40 (BREAS Medical AB)immediately after randomization (when their FVC reaches the threshold of the 75% of the predicted value)
    Intervention: Device: Home pressure ventilator model Vivo 40 (BREAS Medical AB)
  • Active Comparator: standard
    patients in this arm will start non invasive ventilation with home pressure ventilator model Vivo 40 (BREAS Medical AB) when they fulfil at least one of the following criteria: (i) FVC < 50% predicted, (ii) orthopnea, and/or (iii) PaCO2 > 45 mmHg.
    Intervention: Device: Home pressure ventilator model Vivo 40 (BREAS Medical AB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
Not Provided
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Definite ALS diagnosis according to El Escorial Criteria
  • Ability to understand and perform the pulmonary function test
  • FVC ≤ 75% (with FVC registry >75% documented within the six previous months)

Exclusion Criteria:

  • Major comorbidity (non-related with ALS) that can shorten life expectancy
  • Cognitive impairment that prevents the patient to understand and perform the study procedures including technically acceptable pulmonary function tests (FVC, MIP, SNP, PCF)
  • Patient refusal of NIV treatment
  • Previous respiratory or cardiac diseases with known impaired spirometry
  • Indication of NIV according to standard criteria (PaCO2 > 45 mmHg, FVC < 50%, orthopnea)
  • ALS with slow disease progression (more than 3 years)
  • Participation in another clinical trial
Both
18 Years to 80 Years
No
Contact: Eva Farrero, MD 0034 93 2607576 efarrero@bellvitgehospital.cat
Spain
 
NCT01641965
AC 111/11
Yes
Eva Farrero Munoz, Hospital Universitari de Bellvitge
Hospital Universitari de Bellvitge
Fondo de Investigacion Sanitaria
Not Provided
Hospital Universitari de Bellvitge
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP