Skip to content

Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02920684
Enrollment
20
Registered
2016-09-30
Start date
2016-12-31
Completion date
2017-08-31
Last updated
2017-08-02

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

Conditions

Critically Ill Patients Under Mechanical Ventilation, Sedated Patients

Keywords

Early rehabilitation, Mechanical ventilation, Physiotherapy

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.

Interventions

OTHERPassive legs mobilisation

A physiotherapist performs a passive leg movement

OTHERPassive cycloergometer

A motorised cycloergometer performs a passive cycling

A neuromuscular electrical stimulation device performs a quadriceps located stimulation

A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frame
Cardiac output by cardiac ultrasonographyEvery 3 minutes during 10 minutes exercise

Secondary

MeasureTime frame
Muscular oxygenation of vastus lateralis muscle by Near Infrared SpectroscopyContinuously during ten minutes exercise
Pulmonary artery Pressure by cardiac ultrasonographyEvery 3 minutes during 10 minutes exercise
Tricuspid annular plane systolic excursion by cardiac ultrasonographyEvery 3 minutes during 10 minutes exercise
Expiratory volumeContinuously during ten minutes exercise
Respiratory rateContinuously during ten minutes exercise

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026