Validation of a Dynamic Evaluation Tool in Respiratory Failure

NCT01807663 | Terminated

• 1 other identifier: 2012-A01280-43
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

neuromuscular disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Respiratory events in healthy volonteers

  1h

• Respiratory events in chronic Patients

  1-12h

• Respiratory events in acute patients

  1-12h

Study Arms (3)

healthy volunteers

EXPERIMENTAL

Free breath monitoring. Correlation between two device for recording parameters of ventilation.

Device: healthy volonteers; Device: Free breath monitoring

Chronic patient

EXPERIMENTAL

Free breath monitoring. Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) compared with the recording of the PtCO2 and the SpO2)

Device: healthy volonteers; Device: Free breath monitoring

ACUTE PATIENT

EXPERIMENTAL

Free breath monitoring. Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) compared with the recording of the PtCO2 and the SpO2)

Device: healthy volonteers; Device: Free breath monitoring

Interventions

healthy volonteers DEVICE

Monitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period.

Also known as: Visuresp system : wireless inductance plethysmography system

ACUTE PATIENT; Chronic patient; healthy volunteers

Free breath monitoring DEVICE

Monitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period.

Also known as: Visuresp system : wireless inductance plethysmography system

ACUTE PATIENT; Chronic patient; healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead
• Adep Assistance: collaborator

Study Sites (1)

Hopital Raymond Poincare

Garches, Île-de-France Region, 92380, France

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Nervous System Diseases

Study Officials

• DAVID ORLIKOWSKI, MDPHD

  Cic it 805

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDPHD

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 8, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: June 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

FR (1)