Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

University Hospital, Rouen

Status and phase: Completed; Phase 3

Conditions: Sedated Patients; Critically Ill Patients Under Mechanical Ventilation

Treatments: Other: Passive cycloergometer; Other: Muscular electrical stimulation; Other: Passive legs mobilisation; Other: FES cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT02920684

2015-A01633-46

Details and patient eligibility

About

Despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. A recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises applied in intensive care is common and most patients stay in bed.

Under these conditions, the optimal choice of the rehabilitation technique for bedridden patient and its intensity should be studied.

The objective of the study is to evaluate the cardiovascular and metabolic response of patients during four interventions: Passive legs mobilization, Passive cycloergometter, Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mechanical ventilation
• Sedated
• Ramsay < 4

Exclusion criteria

• Rehabilitation contraindication
• Patient with pacemaker
• Patient under volume assist control
• FiO2 > 80%
• Patient under neuromuscular blockers
• Neurologic comorbidity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 4 patient groups

Passive legs mobilisation

Active Comparator group

Description:

A physiotherapist performs passive legs movement

Treatment:

Other: Passive legs mobilisation

Passive cycloergometer

Active Comparator group

Description:

A motorized cycloergometer performs passive legs cycling

Treatment:

Other: Passive cycloergometer

Muscular electrical stimulation

Active Comparator group

Description:

Quadriceps neuromuscular electrical stimulation

Treatment:

Other: Muscular electrical stimulation

FES cycling

Active Comparator group

Description:

A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive

Treatment:

Other: FES cycling