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NCT03352102 Clinical Trial

Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients

Respiration, Artificial Clinical Trial

Official title:
Effects of Neuromuscular Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03352102
Other study ID # 134673
Secondary ID
Status Completed
Phase N/A
First received November 20, 2017
Last updated December 3, 2017
Start date January 1, 2014
Est. completion date July 1, 2016

Study information
Verified date December 2017
Source Universidade Estadual do Oeste do Paraná
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.

Description:

Objective: Evaluate the effectiveness of the Neuro Muscular Electrical Stimulation therapy in quadriceps versus diaphragm subjects on mechanical ventilation (MV). Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date July 1, 2016
Est. primary completion date September 30, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age of 18 years or more

- 24 hours of MV or more

Exclusion Criteria:

Hemodynamic instability, pregnancy, body mass index(BMI) >35 kg/m2, history of neuromuscular disease at admission, brain death, diseases with systemic vascular involvement, bone fractures, use of an internal or external fixator, skin lesions, end-stage cancer, use of pacemakers, spinal injuries, or inability to receive an Medical Research Council score because of the cognitive state.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Electrical stimulation
Neuromuscular electrical stimulation therapy was performed

Locations
Country Name City State
Brazil Hospital Universitário do Oeste do Paraná Cascavel Paraná

Sponsors (1)
Lead Sponsor Collaborator
Pericles Almeida Delfino Duarte

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary ICU and Hospital length of stay Length of stay (in days) in ICU and in hospitalization 60 days
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