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Completed

NCT Number: NCT01968889

ICU Acquired Neuromyopathy and Diaphragm Function

Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a deep weakness involving the respiratory muscle work which result in a delayed weaning of mechanical ventilation.

The main objective is to quantify the loss of diaphragm function by measuring the diaphragm force (using the non invasive method by phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion) in a selected population of patients with critical illness neuromyopathy (defined as a MRC score < 48).

The second end points are to evaluate its incidence, the consequences on the patients outcome (extubation success or failure; ICU stay) and to evaluate the relations between diaphragm function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the Medical Research Council - MRC score).

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Key information

Conditions

Critical Illness Myopathy Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology & Critical Care, St Eloi University

Montpellier, 34000, France

About this study

Diaphragm function will be assessed through phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion (expressed in cmH2O). It will be assessed during a spontaneous breathing trial for each patient with a known critical illness neuromyopathy. The diaphragm (thickness and course) will be studied by ultrasound assessment as well. Peripheral limbs force will be evaluated by the MRC score. A total of 40 analysable patients will be included.

All these measurements will be made at the time of the spontaneous breathing trial (SBT) during the weaning phase. No modification of the clinical practices of the care should be modified by the study. The twitch airway pressure during airway occlusion will be assessed at the begining of the SBT. The other measurements will be performed 30 mn after the SBT if this one will be well tolerated.

Participants will be followed for the duration of ICU stay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MRC score <48
  • ready for weaning from mechanical ventilation

Exclusion criteria

  • previous history of neuromyopathy
  • impossibility to perform a magnetic stimulation
  • cervical spine injury
  • bihemispheric or brain stem lesion

Treatment and study plan

Non invasive phrenic nerve stimulation

Other

Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion

Primary outcomes

  1. Twitch tracheal pressure during airway occlusion (expressed in cmH2O)

    Time frame: At the begining of the spontaneous breathing trial

    According the standard of care of weaning process; to evaluate the readiness of the patient to be extubated, the setting of the ventilator should be set at 7 cmH20 PRESSURE SUPPORT VENTILATION (PSV) level and zero end expiratory pressure (PEEP=0) during spontaneous mechanical ventilation to mimic the spontaneous breathing trial (SBT).

Secondary outcomes

  1. extubation success (defined as no need reintubation during the 48h after extubation)

    Time frame: Day 28 after ICU admission

    Participants will be followed until Day 28 after ICU admission.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Diaphragm Function in Patients Acquired Weakness and Neuromyopathy in ICU: Impact on Weaning and Outcome (DIAPH-WEAK ICU)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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