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Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients

Primary Purpose

Critical Illness Myopathy, Respiration, Artificial

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Electrical stimulation
Sponsored by
Pericles Almeida Delfino Duarte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness Myopathy focused on measuring Electric Stimulation, Intensive Care Units, Mechanical Ventilation, Ventilator Weaning

Eligibility Criteria

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

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.

Sites / Locations

  • Hospital Universitário do Oeste do Paraná

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Diaphragm Group (DG)

Quadriceps Group (QG)

Control Group (CG)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

ICU and Hospital length of stay
Length of stay (in days) in ICU and in hospitalization

Secondary Outcome Measures

Full Information

First Posted
November 20, 2017
Last Updated
December 3, 2017
Sponsor
Pericles Almeida Delfino Duarte
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1. Study Identification

Unique Protocol Identification Number
NCT03352102
Brief Title
Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients
Official Title
Effects of Neuromuscular Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
September 30, 2014 (Actual)
Study Completion Date
July 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pericles Almeida Delfino Duarte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness Myopathy, Respiration, Artificial
Keywords
Electric Stimulation, Intensive Care Units, Mechanical Ventilation, Ventilator Weaning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diaphragm Group (DG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Quadriceps Group (QG)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electrical stimulation
Intervention Description
Neuromuscular electrical stimulation therapy was performed
Primary Outcome Measure Information:
Title
ICU and Hospital length of stay
Description
Length of stay (in days) in ICU and in hospitalization
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pericles Duarte
Organizational Affiliation
Hospital Universitário do Oeste do Parana, Universidade Estadual do Oeste do Parana.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário do Oeste do Paraná
City
Cascavel
State/Province
Paraná
ZIP/Postal Code
85806-470
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients

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