Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock (MUEVELO)

Cycloergometer is a validated method for different care. This kind of device allow passive and active care for patient. The interest of cycloergometer for patient hospitalized in Intensive Care Unit for Sepsis has never been demonstrated.

The main objective of this study is to determine the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients with septic shock

The secondary objectives of this study are to assess the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy on:

1. the duration between hemodynamic stability* and the removal of sedation
2. the duration between the removal of sedation and ICU discharge
3. the mechanical ventilation duration (invasive and noninvasive)

Study Overview

• Status: Terminated
• Conditions: Sepsis
• Intervention / Treatment: Device: Early mobilisation with cyclo ergometer; Other: Standard physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient hospitalized in ICU
• Septic shock diagnosed more than 24 hours before inclusion
• Patient hemodynamically stable, before the 72th hour following the diagnosis of septic shock
• Mechanical ventilation by tracheal intubation
• Patient sedated with a RASS score inferior or equal to -2
• Age ≥ 18 years
• BMI ≤ 40 kg / m²
• Informed patient having signed the consent
• Effective contraception in women of childbearing age (pregnancy test by B-HCG will be done; for menopausal women, a diagnosis of confirmation must be obtained).

Exclusion Criteria:

• BMI> 40kg / m²
• Patient reduced by one or two lower limbs
• Rheumatological pathology, trauma or surgery of the lower limbs, pelvis or spine resulting of any limitations of the range of motions or strict immobilization
• Brain-injured patient and / or medulla injured
• Hemodialysis continues with a femoral catheter without possibility of changing the catheter location
• Moribund patient, Stop or Limitation of Active Therapeutics' decision
• Contraindications to standard physical therapy or the cyclo-ergometer
• Untreated orthopedics: deep vein thrombosis of the member concerned
• Dermatological: severe lesions or complex dressings in the sector concerned
• Patient with ExtraCorporeal Membrane Oxygenation (ECMO)
• Pregnant or breastfeeding women
• Patient participating in another trial with the same main objective

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early mobilisation with cyclo ergometer; Early mobilisation with cyclo ergometer in addition of Standard physiotherapy during sepsis for patient with sepsis in ICU	Device: Early mobilisation with cyclo ergometer; Early mobilisation with cyclo ergometer is done daily during hospitalization for sepsis in an Intensive Care Unit; Other: Standard physiotherapy; Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking
Active Comparator: Standard physiotherapy; Standard physiotherapy during sepsis for patient with sepsis in ICU	Other: Standard physiotherapy; Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days between hemodynamic stability and ICU discharge	Number of days between hemodynamic stability (after beginning of hospitalization for sepsis) and ICU discharge	approximately 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days between hemodynamic stability and the removal of sedation	Number of days between hemodynamic stability (after beginning of hospitalization for sepsis) and the removal of sedation	From 3 to 10 days
Number of days under mechanical ventilation (invasive and noninvasive) during hospitalization in ICU	Number of days under mechanical ventilation (invasive and noninvasive, (after beginning of hospitalization for sepsis) ) during hospitalization in ICU	From 3 to 10 days

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Gaétan BEDUNEAU, MD, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2016
• Primary Completion (Actual): April 21, 2020
• Study Completion (Actual): April 21, 2020

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: cycloergometer
• Other Study ID Numbers: 2014/211/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO