Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness Myopathy; Respiration, Artificial
• Intervention / Treatment: Procedure: Electrical stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Cascavel, Paraná, Brazil, 85806-470
      • Hospital Universitário do Oeste do Paraná

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diaphragm Group (DG); subjects who received conventional physical therapy once a day, plus a daily session of electrical stimulation in the diaphragm. Intervention: Electrical stimulation of the diaphragm.	Procedure: Electrical stimulation; Neuromuscular electrical stimulation therapy was performed
Active Comparator: Quadriceps Group (QG); subjects who also received conventional physical therapy once a day, plus a daily session of electrical stimulation in the quadriceps. Intervention: Electrical stimulation of the quadriceps.	Procedure: Electrical stimulation; Neuromuscular electrical stimulation therapy was performed
No Intervention: Control Group (CG); subjects who received regular treatment, i.e., conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day, including weekend, during their stay in the ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU and Hospital length of stay	Length of stay (in days) in ICU and in hospitalization	60 days

Collaborators and Investigators

• Sponsor: Pericles Almeida Delfino Duarte
• Investigators: Principal Investigator: Pericles Duarte, Hospital Universitário do Oeste do Parana, Universidade Estadual do Oeste do Parana.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): September 30, 2014
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 3, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Intensive Care Units; Ventilator Weaning; Electric Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 134673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No