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Completed

NCT Number: NCT02920684

Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

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.

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Key information

Conditions

Critically Ill Patients Under Mechanical Ventilation Sedated Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Le Havre, Jacques Monod Hospital

Montivilliers, 76290, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive legs mobilisation

Other

A physiotherapist performs a passive leg movement

Passive cycloergometer

Other

A motorised cycloergometer performs a passive cycling

Muscular electrical stimulation

Other

A neuromuscular electrical stimulation device performs a quadriceps located stimulation

FES cycling

Other

A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation

Primary outcomes

  1. Cardiac output by cardiac ultrasonography

    Time frame: Every 3 minutes during 10 minutes exercise

Secondary outcomes

  1. Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy

    Time frame: Continuously during ten minutes exercise

  2. Pulmonary artery Pressure by cardiac ultrasonography

    Time frame: Every 3 minutes during 10 minutes exercise

  3. Tricuspid annular plane systolic excursion by cardiac ultrasonography

    Time frame: Every 3 minutes during 10 minutes exercise

  4. Expiratory volume

    Time frame: Continuously during ten minutes exercise

  5. Respiratory rate

    Time frame: Continuously during ten minutes exercise

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2016
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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