Ignite Creation Date:
2024-05-06 @ 12:43 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01641965
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2012-07-13
Brief Title:
Impact of Early Non Invasive Ventilation in Amyotrophic Lateral Sclerosis ALS Patients
Sponsor:
Hospital Universitari de Bellvitge
Organization:
Hospital Universitari de Bellvitge
Study Overview
Official Title:
Impact of Early Non-invasive Ventilation in Amyotrophic Lateral Sclerosis Patients a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 objectivesTo 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 andor 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
Principal objective To evaluate the impact of early NIV in the survival of ALS patients
Secondary objectivesTo 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 andor 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
Detailed Description:
ALS patients with early impairment of respiratory muscles FVC around 75 will be radomised to initiate NIV or conventional follow-up
The NIV treatment will be initiated during a hospital with the model of ventilator VIVO 40 BREAS Medical AD Sweden using a pressure support assistedcontrol mode with a minimum pressure support 10 cm
Initial NIV indication in both groups of patients will nocturnal Patients will be defined as tolerant to NIV if they do not refer inconveniences and is able to asleep with NIV
The efficacy of the intervention will be compared in both groups with survival until death or change to invasive tracheal ventilation as a prymary efficacy parameter
The NIV treatment will be initiated during a hospital with the model of ventilator VIVO 40 BREAS Medical AD Sweden using a pressure support assistedcontrol mode with a minimum pressure support 10 cm
Initial NIV indication in both groups of patients will nocturnal Patients will be defined as tolerant to NIV if they do not refer inconveniences and is able to asleep with NIV
The efficacy of the intervention will be compared in both groups with survival until death or change to invasive tracheal ventilation as a prymary efficacy parameter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None