Diaphragmatic Atrophy Related to Mechanical Ventilation

NCT02766946 | Completed

• 1 other identifier: SJSL12013
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Septic Shock; Acute Respiratory Distress

Keywords

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Change from day 1 diaphragm thickness at day 3 and day 5

  Diaphragm thickness measured by ultrasound

  1 day, 3 days and 5 days after introduction of Mechanical Ventilation

Secondary Outcomes (15)

• Diaphragm thickness measured by ultrasound

  10 days after introduction of Mechanical Ventilation

• Type of ventilatory support

  10 days after start of ventilatory support

• Ventilatory mode

  10 days after start of ventilatory support

• Pectoralis muscle thickness measured by ultrasound

  10 days after start of ventilatory support

• Diaphragmatic strength

  intraoperative

Study Arms (3)

Mechanical Ventilation

EXPERIMENTAL

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

Device: Ultrasound; Other: Neuromyopathy score; Other: Respiratory performances

Non-invasive Ventilation

ACTIVE COMPARATOR

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

Device: Ultrasound; Other: Neuromyopathy score; Other: Respiratory performances

Spontaneous Ventilation

ACTIVE COMPARATOR

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

Device: Ultrasound; Other: Neuromyopathy score; Other: Respiratory performances

Interventions

Ultrasound DEVICE

An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10

Mechanical Ventilation; Non-invasive Ventilation; Spontaneous Ventilation

Neuromyopathy score OTHER

A neuromyopathy score will be assessed on the extubation day

Mechanical Ventilation; Non-invasive Ventilation; Spontaneous Ventilation

Respiratory performances OTHER

An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure

Mechanical Ventilation; Non-invasive Ventilation; Spontaneous Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead

MeSH Terms

Conditions

Shock, Septic; Acute Lung Injury

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 10, 2016
• Study Start: June 24, 2013
• Primary Completion: December 17, 2015
• Study Completion: December 22, 2015
• Last Updated: April 4, 2024

Record last verified: 2024-04