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Diaphragmatic Atrophy Related to Mechanical Ventilation

Ultrasound Observation of Diaphragmatic Atrophy Related to Mechanical Ventilation A Prospective Monocentric Study in Intensive Care Unit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02766946
Acronym
ECHODIAPH
Enrollment
97
Registered
2016-05-10
Start date
2013-06-24
Completion date
2015-12-22
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress, Septic Shock

Keywords

Mechanical Ventilation

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.

Interventions

DEVICEUltrasound

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

OTHERNeuromyopathy score

A neuromyopathy score will be assessed on the extubation day

OTHERRespiratory performances

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

Sponsors

Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from day 1 diaphragm thickness at day 3 and day 51 day, 3 days and 5 days after introduction of Mechanical VentilationDiaphragm thickness measured by ultrasound

Secondary

MeasureTime frameDescription
Type of ventilatory support10 days after start of ventilatory supportDefine which type of ventilatory support is used (mechanical ventilation, non-invasive ventilation, or spontaneous ventilation)
Ventilatory mode10 days after start of ventilatory supportVentilatory mode (controlled ventilation, pressure support ventilation)
Pectoralis muscle thickness measured by ultrasound10 days after start of ventilatory supportTo compare the importance of this atrophy to those of diaphragmatic muscle
Diaphragmatic strengthintraoperativeRelation between diaphragmatic atrophy and decrease of diaphragmatic strength
Early or late extubation failure rate (extubation performed before or after 48 hours)The last day of hospitalisationRelation between diaphragmatic atrophy importance and premature (\<48h) or late extubation failure
MRC score (Medical Research Council)intraoperativeRelation between diaphragmatic atrophy and decrease of diaphragmatic strength
Length of ventilation in hours10 days after start of ventilatory support
Diaphragm thickness measured by ultrasound10 days after introduction of Mechanical Ventilation
Total positive end expiratory pressure10 days after start of ventilatory support
External positive end expiratory pressure10 days after start of ventilatory support
Respiratory rate10 days after start of ventilatory support
Highest inspiratory pressure level10 days after start of ventilatory support
Highest expiratory pressure level10 days after start of ventilatory support
Volume of exhaled air10 days after start of ventilatory support
Drug administration10 days after start of ventilatory supportPresence of drug administration such as curare, corticoid or sedative. If yes : number of days with treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026