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Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients

NCT ID: NCT03352102

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2016-07-01

Brief Summary

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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

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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.

Conditions

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Critical Illness Myopathy Respiration, Artificial

Keywords

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Electric Stimulation Intensive Care Units Mechanical Ventilation Ventilator Weaning

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Electrical stimulation

Intervention Type PROCEDURE

Neuromuscular electrical stimulation therapy was performed

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.

Group Type ACTIVE_COMPARATOR

Electrical stimulation

Intervention Type PROCEDURE

Neuromuscular electrical stimulation therapy was performed

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electrical stimulation

Neuromuscular electrical stimulation therapy was performed

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pericles Almeida Delfino Duarte

OTHER

Sponsor Role lead

Responsible Party

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Pericles Almeida Delfino Duarte

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pericles Duarte

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitário do Oeste do Parana, Universidade Estadual do Oeste do Parana.

Locations

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Hospital Universitário do Oeste do Paraná

Cascavel, Paraná, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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134673

Identifier Type: -

Identifier Source: org_study_id