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

NCT ID: NCT02872792

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-14
• Study Completion Date: 2020-04-21

Brief Summary

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)

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early mobilisation with cyclo ergometer

Early mobilisation with cyclo ergometer in addition of Standard physiotherapy during sepsis for patient with sepsis in ICU

Group Type: EXPERIMENTAL

Early mobilisation with cyclo ergometer

Intervention Type: DEVICE

Early mobilisation with cyclo ergometer is done daily during hospitalization for sepsis in an Intensive Care Unit

Standard physiotherapy

Intervention Type: OTHER

Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking

Standard physiotherapy

Standard physiotherapy during sepsis for patient with sepsis in ICU

Group Type: ACTIVE_COMPARATOR

Standard physiotherapy

Intervention Type: OTHER

Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking

Interventions

Early mobilisation with cyclo ergometer

Early mobilisation with cyclo ergometer is done daily during hospitalization for sepsis in an Intensive Care Unit

Intervention Type: DEVICE

Standard physiotherapy

Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaétan BEDUNEAU, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2014/211/HP

Identifier Type: -

Identifier Source: org_study_id