Clinical trial NCT01807663: Validation of a Dynamic Evaluation Tool in Respiratory Failure
Official title: Validation of a Dynamic Evaluation Tool in Respiratory Failure by Ambulatory Inductance Plethysmography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Failure
Keywords: neuromuscular disease
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Adep Assistance
First posted: 2013-03-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Determing optimal time of ventilator disconnection is a challenge for both acute and chronic neuromuscular disease. In one case it is helpful for weanning from ventilator and in the other to optimize daytime ventilation in the most severe patients. The investigators propose to validate a new non invasive tool for monitoring respiratroy parameters in neuromuscular patients in both acute and chronic conditions.

Detailed description: Context:

Mechanical ventilation transformed the prognosis of neuromuscular diseases whether for acute or chronic diseases. The available tools to estimate the severity of respiratory insufficiency and indicate or follow the efficiency of mechanical ventilation are based on blood gazes explorations, tests respiratory function and sleep evaluation.

These tools give either limited information, or are with difficulty applicable to patients heavily handicapped except during hospitalization.

In patients under mechanical ventilation, it is sometimes difficult to know the daily optimal time of ventilation. The respiratory events are not generally recognized and are unspecific (headaches, drowsiness, dyspnoea, etc.) or are identified by blood gazes abnormalities (hypercapnia. In acute setting, treble is going to raise the problem of the weaning of the mechanical ventilation and the optimal moment of the extubation without risking a reintubation.

These problems are identical and concern the evaluation of the degree of ventilatory autonomy for home care. The development of methods estimating this autonomy is thus fundamental.

Objectives: the objective of this project is to validate a non-invasive system for measure and acquisition of respiratory parameters, incorporating a transmission system working by a "wireless" technology allowing the remote monitoring of these patients.

The secondary objectives are to determine the parameters of success of weaning by using the device in neuromuscular patients intubated for respiratory failure in acute setting and to determine the optimal time of free breathing possibilities in patients ventilated in a chronic way at home.

Methods:

After validation of the device on 10 healthy subjects, continuous acquisition of the ventilatory data by means of the Teleresp system compared with measure of the transcutaneous PCO2, of SaO2 and arterial gazometry at the end of free breath trial in 40 acute and chronic neuromuscular patients.

Selection criteria:

Healthy volunteers Patients affected by acute neuromuscular pathology and starting weaning from invasive ventilation (Guillain Barré and myasthenia).

Patients affected by neuromuscular pathology and home ventilated in a diurnal and night-way by invasive interface or not (respiratory autonomy of at least 1:00 am).

Number of patients, center:

10 healthy volunteers and 40 patients hospitalized in the intensive care unit or in the home of ventilation unit of the Raymond Poincaré hospital.

Total duration of the study: 19 months

Eligibility criteria: Inclusion Criteria:

Healthy volonteers Man or woman of more than 18 years Realization of a preliminary medical examination Patient having signed an informed and written consent Major healthy subjects, presenting no chronic pathology or not chronic patients

Chronic patients Man or woman of more than 18 years Affected by neuromuscular pathology Realization of a preliminary medical examination Patient in the stable state at the time of the study for at least 1 month Ventilated in a not invasive or invasive way in diurnal and night-period. Respiratory autonomy \> 1:00 am Patient having signed an informed and written consent

Acute Patients Man or woman of more than 18 years Affected by syndrome of Guillain blocked in aigue phase having required the invasive ventilation or affected by myasthenia generalized with myasthénique crisis having required the invasive ventilation.

Realization of a preliminary medical examination Patient in phase of neurological recovery Vital Capacity \> 15 ml / kg Respiratory Autonomy \> 1:00 am Patient having signed a lit(enlightened) and written consent

Exclusion Criteria:

Healthy volonteers subject refusing to participate in the study subject under guardianship or guardianship Pregnant or breast-feeding Woman

Chronic patients Patient refusing to participate in the study Patient under guardianship or guardianship Pregnant or breast-feeding Woman Patients ventilated only at night Clinically significant bronchial Dimensions(Congestion) Required by oxygen therapy

Acute patients Patient refusing to participate in the study Patient or subject under guardianship or guardianship Pregnant or breast-feeding Woman Clinically significant bronchial Dimensions(Congestion) Required by oxygen therapy FIO2 \> 40 % PEP \> 5 cms H2O State of shock

Primary outcomes:
measure: Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) detected with regard to the recording of the PtCO2 and the SpO2
timeFrame: 1 to 12 hours
Secondary outcomes:
measure: Respiratory events in healthy volonteers
timeFrame: 1h
measure: Respiratory events in chronic Patients
timeFrame: 1-12h
measure: Respiratory events in acute patients
timeFrame: 1-12h
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
state: Ile de France
Study officials:
affiliation: Cic it 805
name: DAVID ORLIKOWSKI, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modalités pratiques de la ventialtion non invasive en pression positive, au long cours, a domicile, dans les maladies neuromusculaires. Rev Mal Respir 2006;23:S3-S40. Toussaint M, Steens M, Wasteels G, Soudon P. Diurnal ventilation via mouthpiece: survival in end-stage Duchenne patients. Eur Respir J 2006;28(3):549-55. Seneviratne J, Mandrekar J, Wijdicks EF, Rabinstein AA. Predictors of extubation failure in myasthenic crisis. Arch Neurol 2008;65(7):929-33. Prigent H, Orlikowski D, Letilly N, Falaize L, Annane D, Sharshar T, et al. Vital Capacity Versus Maximal Inspiratory Pressure in Patients with Guillain-Barre Syndrome and Myasthenia Gravis. Neurocrit Care. Kohler M, Clarenbach CF, Bahler C, Brack T, Russi EW, Bloch KE. Disability and survival in Duchenne muscular dystrophy. J Neurol Neurosurg Psychiatry 2009;80(3):320-5. Brouillette RT, Morrow AS, Weese-Mayer DE, Hunt CE. Comparison of respiratory inductive plethysmography and thoracic impedance for apnea monitoring. J Pediatr 1987;111(3):377-83. Calabrese P, Besleaga T, Eberhard A, Vovc V, Baconnier P. Respiratory inductance plethysmography is suitable for voluntary hyperventilation test. Conf Proc IEEE Eng Med Biol Soc 2007;2007:1055-7. Eberhard A, Calabrese P, Baconnier P, Benchetrit G. Comparison between the respiratory inductance plethysmography signal derivative and the airflow signal. Adv Exp Med Biol 2001;499:489-94. Redline S, Budhiraja R, Kapur V, Marcus CL, Mateika JH, Mehra R, et al. The scoring of respiratory events in sleep: reliability and validity. J Clin Sleep Med 2007;3(2):169-200.