Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 6:00 AM
Study NCT ID:
NCT00839033
Status:
TERMINATED
Last Update Posted:
2015-05-28
First Post:
2009-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Mechanical Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Evaluation of a Mechanical Insufflation-exsufflation Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders: a Prospective, Randomized, Controlled, Multicenter Study
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nemucough
Brief Summary:
The hypothesis is that a mechanical insufflation-exsufflation (MI-E) is associated with a decrease in the number of intubations and more rapid clinical improvement in children and adults with neuromuscular disease who are admitted for an acute respiratory exacerbation.In this prospective, randomised, multicenter study, 55 patients will be treated with standard treatment and a MI-E, and 55 patients with standard treatment and standard respiratory physiotherapy. The primary objective is the reduction of the number of patients requiring invasive ventilatory support (endotracheal intubation or tracheotomy) in the group treated with MI-E (MI-E group). The main secondary objectives are a reduction in hospital stay and an improvement in clinical condition, dyspnea and respiratory muscle function.
Detailed Description:
Justification Respiratory muscle weakness reduces the efficacy of the cough reflex in patients with neuromuscular disorders and exposes them to the risk of acute respiratory failure. Mechanical insufflation-exsufflation devices assist cough and have been shown to be efficient in increasing the cough expiratory flow in children and adults with neuromuscular disease and decreasing the risk of intubation in a limited population of hospitalized adults with acute respiratory failure.
Primary objective The goal is to record the efficacy of mechanical insufflation-exsufflation (MI-E) during acute respiratory failure in patients with neuromuscular disorders.The primary objective is the reduction of the number of patients requiring invasive ventilatory support (endotracheal intubation or tracheotomy) in the group treated with MI-E (MI-E group) compared to the group treated with traditional chest physiotherapy without MI-E (Control group).
Secondary objectives
In the MI-E group, compared to the Control group:
1. Decrease in the length of hospitalization in the intensive care unit (ICU)
2. Decrease in the total length of hospitalization
3. Decrease in the incidence of bronchoscopy-assisted aspiration
4. Decrease in the duration of oxygen therapy
5. Decrease in the daily length of noninvasive positive pressure ventilation (NPPV)
6. Improvement in blood gases on room air during hospitalization
7. Improvement of the peak cough flow (PCF)
8. Improvement of the vital capacity (VC), maximal inspiratory (PImax) and expiratory (PEmax) pressures, sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF) and dyspnea during hospitalization.
9. Decrease in the number of secondary tracheotomies (for weaning of ventilatory support)
Type of study Prospective, randomized, controlled, multicenter study
Number of subjects The calculation of the number of subjects is based on two retrospective studies. In the study by VIANELLO, which included 11 adults hospitalized in the ICU for respiratory failure, the number of therapeutic failures, defined as the need for a "mini" tracheotomy or intubation, was significantly less in the group using MI-E than in a group of 16 historical control patients \[2 failures in the MI-E group (18%) versus 10 failures in the control group (63%), p\<0.05\] (1). Another study reported 19 successes (80%) versus 5 failures on MI-E (2).
Primary objective The goal is to record the efficacy of mechanical insufflation-exsufflation (MI-E) during acute respiratory failure in patients with neuromuscular disorders.The primary objective is the reduction of the number of patients requiring invasive ventilatory support (endotracheal intubation or tracheotomy) in the group treated with MI-E (MI-E group) compared to the group treated with traditional chest physiotherapy without MI-E (Control group).
Secondary objectives
In the MI-E group, compared to the Control group:
1. Decrease in the length of hospitalization in the intensive care unit (ICU)
2. Decrease in the total length of hospitalization
3. Decrease in the incidence of bronchoscopy-assisted aspiration
4. Decrease in the duration of oxygen therapy
5. Decrease in the daily length of noninvasive positive pressure ventilation (NPPV)
6. Improvement in blood gases on room air during hospitalization
7. Improvement of the peak cough flow (PCF)
8. Improvement of the vital capacity (VC), maximal inspiratory (PImax) and expiratory (PEmax) pressures, sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF) and dyspnea during hospitalization.
9. Decrease in the number of secondary tracheotomies (for weaning of ventilatory support)
Type of study Prospective, randomized, controlled, multicenter study
Number of subjects The calculation of the number of subjects is based on two retrospective studies. In the study by VIANELLO, which included 11 adults hospitalized in the ICU for respiratory failure, the number of therapeutic failures, defined as the need for a "mini" tracheotomy or intubation, was significantly less in the group using MI-E than in a group of 16 historical control patients \[2 failures in the MI-E group (18%) versus 10 failures in the control group (63%), p\<0.05\] (1). Another study reported 19 successes (80%) versus 5 failures on MI-E (2).
Study Oversight
Has Oversight DMC:
False
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?: