Validation of a Dynamic Evaluation Tool in Respiratory Failure

Respiratory Failure Clinical Trial

— TELERESP  

Official title:

Validation of a Dynamic Evaluation Tool in Respiratory Failure by Ambulatory Inductance Plethysmography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01807663
• Other study ID #: 2012-A01280-43
• Status: Terminated
• Phase: N/A
• First received: February 26, 2013
• Last updated: September 25, 2014
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• healthy volonteers
Monitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period.
• Free breath monitoring
Monitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period.

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches	Ile de France

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Adep Assistance

Country where clinical trial is conducted

France, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) detected with regard to the recording of the PtCO2 and the SpO2	Healthy subjects will be recorded for one hour in seated positions 30 minutes and slept 30 min.; Pneumotachograph recording will be realized during 5 minutes at the beginning and at the end of every phase of recording. The computer assuring the reception of the signals being remotely located to estimate of the transmission.; All the patients will be registered in parallel with the VISURESP ® system (RBI Grenoble, France) and the measure of the transcutaneous PCO2 and SpO2(SenTec AG, Therwil, Switzerland) during free breath. The measure beginning 30 minutes before the logout and finishing 30 minutes later.; Acute patients being able to like at least 2 H of free breath will be recorded. A first measure will be made dice that a free breath of at least 2H will be possible, then 3 days later and the day the extubation. Aterial blood gazes will be obtained before reconnection. Chronic patients willbe recorded if able to be disconnected from ventilator for more than 1 hour.	1 to 12 hours	No
Secondary	Respiratory events in healthy volonteers	Quality of data transmission of respiratory paramaters	1h	No
Secondary	Respiratory events in chronic Patients	Correlation between the number of event detected by VISURESP ®, the duration of hypercapnie superior to 45 mmHg on the PtCO2 and the gazométrie at the end of free Breath.	1-12h	No
Secondary	Respiratory events in acute patients	Correlations between the number of events detected by the technology VISURESP ®, the duration of hypercapnie superior to 45 mmHg on the PtCO2 and the success of the extubation (at least 24 a hour)	1-12h	No