Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

Phase 3

Completed

• Conditions: Sedated Patients; Critically Ill Patients Under Mechanical Ventilation
• Interventions: Other: FES cycling; Other: Passive legs mobilisation; Other: Passive cycloergometer; Other: Muscular electrical stimulation

• Registration Number: NCT02920684
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-25
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Study Start: 2016-12
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FES cycling	FES cycling	A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive
Passive legs mobilisation	Passive legs mobilisation	A physiotherapist performs passive legs movement
Passive cycloergometer	Passive cycloergometer	A motorized cycloergometer performs passive legs cycling
Muscular electrical stimulation	Muscular electrical stimulation	Quadriceps neuromuscular electrical stimulation

Primary Outcome Measures

Name	Time	Method
Cardiac output by cardiac ultrasonography	Every 3 minutes during 10 minutes exercise

Secondary Outcome Measures

Name	Time	Method
Expiratory volume	Continuously during ten minutes exercise
Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy	Continuously during ten minutes exercise
Pulmonary artery Pressure by cardiac ultrasonography	Every 3 minutes during 10 minutes exercise
Respiratory rate	Continuously during ten minutes exercise
Tricuspid annular plane systolic excursion by cardiac ultrasonography	Every 3 minutes during 10 minutes exercise

Trial Locations

Locations (1)

Le Havre, Jacques Monod Hospital; 🇫🇷 Montivilliers, France