Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

Sedated Patients Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920684
• Other study ID #: 2015-A01633-46
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2016
• Last updated: August 1, 2017
• Start date: December 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients Under Mechanical Ventilation
• Sedated Patients

Intervention

Other:
• Passive legs mobilisation
A physiotherapist performs a passive leg movement
• Passive cycloergometer
A motorised cycloergometer performs a passive cycling
• Muscular electrical stimulation
A neuromuscular electrical stimulation device performs a quadriceps located stimulation
• FES cycling
A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation

Locations

Country	Name	City	State
France	Le Havre, Jacques Monod Hospital	Montivilliers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output by cardiac ultrasonography		Every 3 minutes during 10 minutes exercise
Secondary	Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy		Continuously during ten minutes exercise
Secondary	Pulmonary artery Pressure by cardiac ultrasonography		Every 3 minutes during 10 minutes exercise
Secondary	Tricuspid annular plane systolic excursion by cardiac ultrasonography		Every 3 minutes during 10 minutes exercise
Secondary	Expiratory volume		Continuously during ten minutes exercise
Secondary	Respiratory rate		Continuously during ten minutes exercise