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Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

Primary Purpose

Critically Ill Patients Under Mechanical Ventilation, Sedated Patients

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Passive legs mobilisation
Passive cycloergometer
Muscular electrical stimulation
FES cycling
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill Patients Under Mechanical Ventilation focused on measuring Early rehabilitation, Mechanical ventilation, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Le Havre, Jacques Monod Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Passive legs mobilisation

Passive cycloergometer

Muscular electrical stimulation

FES cycling

Arm Description

A physiotherapist performs passive legs movement

A motorized cycloergometer performs passive legs cycling

Quadriceps neuromuscular electrical stimulation

A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive

Outcomes

Primary Outcome Measures

Cardiac output by cardiac ultrasonography

Secondary Outcome Measures

Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy
Pulmonary artery Pressure by cardiac ultrasonography
Tricuspid annular plane systolic excursion by cardiac ultrasonography
Expiratory volume
Respiratory rate

Full Information

First Posted
September 25, 2016
Last Updated
August 1, 2017
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02920684
Brief Title
Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients Under Mechanical Ventilation, Sedated Patients
Keywords
Early rehabilitation, Mechanical ventilation, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive legs mobilisation
Arm Type
Active Comparator
Arm Description
A physiotherapist performs passive legs movement
Arm Title
Passive cycloergometer
Arm Type
Active Comparator
Arm Description
A motorized cycloergometer performs passive legs cycling
Arm Title
Muscular electrical stimulation
Arm Type
Active Comparator
Arm Description
Quadriceps neuromuscular electrical stimulation
Arm Title
FES cycling
Arm Type
Active Comparator
Arm Description
A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive
Intervention Type
Other
Intervention Name(s)
Passive legs mobilisation
Intervention Description
A physiotherapist performs a passive leg movement
Intervention Type
Other
Intervention Name(s)
Passive cycloergometer
Intervention Description
A motorised cycloergometer performs a passive cycling
Intervention Type
Other
Intervention Name(s)
Muscular electrical stimulation
Intervention Description
A neuromuscular electrical stimulation device performs a quadriceps located stimulation
Intervention Type
Other
Intervention Name(s)
FES cycling
Intervention Description
A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation
Primary Outcome Measure Information:
Title
Cardiac output by cardiac ultrasonography
Time Frame
Every 3 minutes during 10 minutes exercise
Secondary Outcome Measure Information:
Title
Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy
Time Frame
Continuously during ten minutes exercise
Title
Pulmonary artery Pressure by cardiac ultrasonography
Time Frame
Every 3 minutes during 10 minutes exercise
Title
Tricuspid annular plane systolic excursion by cardiac ultrasonography
Time Frame
Every 3 minutes during 10 minutes exercise
Title
Expiratory volume
Time Frame
Continuously during ten minutes exercise
Title
Respiratory rate
Time Frame
Continuously during ten minutes exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Le Havre, Jacques Monod Hospital
City
Montivilliers
ZIP/Postal Code
76290
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29703223
Citation
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.
Results Reference
derived
PubMed Identifier
28255448
Citation
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.
Results Reference
derived

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Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

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