Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

NCT ID: NCT02920684

Last Updated: 2017-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Critically Ill Patients Under Mechanical Ventilation Sedated Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Passive legs mobilisation

A physiotherapist performs passive legs movement

Group Type ACTIVE_COMPARATOR

Passive legs mobilisation

Intervention Type OTHER

A physiotherapist performs a passive leg movement

Passive cycloergometer

A motorized cycloergometer performs passive legs cycling

Group Type ACTIVE_COMPARATOR

Passive cycloergometer

Intervention Type OTHER

A motorised cycloergometer performs a passive cycling

Muscular electrical stimulation

Quadriceps neuromuscular electrical stimulation

Group Type ACTIVE_COMPARATOR

Muscular electrical stimulation

Intervention Type OTHER

A neuromuscular electrical stimulation device performs a quadriceps located stimulation

FES cycling

A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive

Group Type ACTIVE_COMPARATOR

FES cycling

Intervention Type OTHER

A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation

Interventions

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Passive legs mobilisation

A physiotherapist performs a passive leg movement

Intervention Type OTHER

Passive cycloergometer

A motorised cycloergometer performs a passive cycling

Intervention Type OTHER

Muscular electrical stimulation

A neuromuscular electrical stimulation device performs a quadriceps located stimulation

Intervention Type OTHER

FES cycling

A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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BOUCHRA LAMIA

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Le Havre, Jacques Monod Hospital

Montivilliers, , France

Site Status

Countries

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France

References

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Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Dupuis Lozeron E, Frenoy E, Contal O, Lamia B. Comparison of exercise intensity during four early rehabilitation techniques in sedated and ventilated patients in ICU: a randomised cross-over trial. Crit Care. 2018 Apr 27;22(1):110. doi: 10.1186/s13054-018-2030-0.

Reference Type DERIVED
PMID: 29703223 (View on PubMed)

Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Frenoy E, Contal O, Lamia B. Effects of different early rehabilitation techniques on haemodynamic and metabolic parameters in sedated patients: protocol for a randomised, single-bind, cross-over trial. BMJ Open Respir Res. 2017 Jan 30;4(1):e000173. doi: 10.1136/bmjresp-2016-000173. eCollection 2017.

Reference Type DERIVED
PMID: 28255448 (View on PubMed)

Other Identifiers

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2015-A01633-46

Identifier Type: -

Identifier Source: org_study_id

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