Diaphragmatic Atrophy Related to Mechanical Ventilation (ECHODIAPH)

C

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Status

Completed

Conditions

Acute Respiratory Distress
Septic Shock

Treatments

Device: Ultrasound
Other: Respiratory performances
Other: Neuromyopathy score

Study type

Interventional

Funder types

Other

Identifiers

NCT02766946
SJSL12013

Details and patient eligibility

About

Ventilatory support during critical phase result in inactivity of respiratory muscles especially diaphragm muscle. These inactivity also result in change of contractile capability and quick muscular atrophy. The aim of the study is to visualize the evolution of diaphragm thickness by echography during Mechanical Ventilation for patients with septic shock or acute respiratory distress syndrome and to compare with the evolution for patients under non-invasive ventilation and those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day 10 (if patient still under a mode of ventilation or in the unit). The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy, which is not involved in ventilation, in order to assess respective effect of ventilatory inactivity and undernutrition linked to intensive care.

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥18 years old
  • Group 1 : under Mechanical Ventilation (time of Mechanical Ventilation for at least 5 days)
  • Group 2 : under Non-invasive Ventilation
  • Group 3 : Spontaneous Ventilation
  • Non opposition of patient (Groups 2 and 3) or non-opposition of patient family member (Group 1)

Exclusion criteria

  • Known diaphragmatic paralysis
  • Neurologic pathology with motor deficit
  • Pregnancy or breast-feeding woman

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

97 participants in 3 patient groups

Mechanical Ventilation
Experimental group
Description:
Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Mechanical Ventilation Interventions : Ultrasound of the right diaphragm Ultrasound of the pectoral muscle Neuromyopathy score Respiratory performances
Treatment:
Other: Neuromyopathy score
Other: Respiratory performances
Device: Ultrasound
Non-invasive Ventilation
Active Comparator group
Description:
Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Non-invasive Ventilation Interventions : Ultrasound of the right diaphragm Ultrasound of the pectoral muscle Neuromyopathy score Respiratory performances
Treatment:
Other: Neuromyopathy score
Other: Respiratory performances
Device: Ultrasound
Spontaneous Ventilation
Active Comparator group
Description:
Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Spontaneous Ventilation Interventions : Ultrasound of the right diaphragm Ultrasound of the pectoral muscle Neuromyopathy score Respiratory performances
Treatment:
Other: Neuromyopathy score
Other: Respiratory performances
Device: Ultrasound

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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