Clinical Trial: Evaluation of a Mechanical Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Evaluation of a Mechanical Insufflation-exsufflation Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders: a Prospective, Randomized, Controlled, Multicenter Study

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 Summary:

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 in
    Sponsor: Assistance Publique - Hôpitaux de Paris

    Current Primary Outcome: Reduction of the number of patients requiring invasive ventilatory support in the group treated with MI-E (MI-E group) compared to the group treated with traditional chest physiotherapy without MI-E (Control group). [ Time Frame: During the treatment phase ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Decrease in the length of hospitalization in the intensive care unit (ICU) (if necessary) [ Time Frame: During the treatment phase ]
    • Decrease in the total length of hospitalization [ Time Frame: During the treatment phase ]
    • Decrease in the incidence of bronchoscopy-assisted aspiration [ Time Frame: During the treatment phase ]
    • Decrease in the duration of oxygen therapy [ Time Frame: During the treatment phase ]
    • Decrease in the daily length of noninvasive positive pressure ventilation (NPPV) [ Time Frame: During the treatment phase ]
    • Improvement in blood gases on room air during hospitalization and improvement of the peak cough flow (PCF) [ Time Frame: During the treatment phase ]
    • 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 [ Time Frame: During the treatment phase ]
    • Decrease in the number of secondary tracheotomies (for weaning of ventilatory support) [ Time Frame: During the treatment phase ]


    Original Secondary Outcome: Same as current

    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: February 6, 2009
    Date Started: June 2009
    Date Completion:
    Last Updated: May 27, 2015
    Last Verified: May 2015