Clinical trial NCT02920684: Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critically Ill Patients Under Mechanical Ventilation
Sedated Patients
Keywords: Early rehabilitation
Mechanical ventilation
Physiotherapy
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cardiac output by cardiac ultrasonography
timeFrame: Every 3 minutes during 10 minutes exercise
Secondary outcomes:
measure: Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy
timeFrame: Continuously during ten minutes exercise
measure: Pulmonary artery Pressure by cardiac ultrasonography
timeFrame: Every 3 minutes during 10 minutes exercise
measure: Tricuspid annular plane systolic excursion by cardiac ultrasonography
timeFrame: Every 3 minutes during 10 minutes exercise
measure: Expiratory volume
timeFrame: Continuously during ten minutes exercise
measure: Respiratory rate
timeFrame: Continuously during ten minutes exercise
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Le Havre, Jacques Monod Hospital
Study officials:
References:
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.
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.