Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients

NCT03352102 | Completed

• 1 other identifier: 134673
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness Myopathy; Respiration, Artificial

Keywords

Electric Stimulation; Intensive Care Units; Mechanical Ventilation; Ventilator Weaning

Outcome Measures

Primary Outcomes (1)

• ICU and Hospital length of stay

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

  60 days

Study Arms (3)

Diaphragm Group (DG)

EXPERIMENTAL

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

Quadriceps Group (QG)

ACTIVE COMPARATOR

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

Control Group (CG)

NO INTERVENTION

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.

Interventions

Electrical stimulation PROCEDURE

Neuromuscular electrical stimulation therapy was performed

Diaphragm Group (DG); Quadriceps Group (QG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or more
• hours of MV or more

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pericles Almeida Delfino Duarte: lead

Study Sites (1)

Hospital Universitário do Oeste do Paraná

Cascavel, Paraná, 85806-470, Brazil

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Pericles Duarte

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: January 1, 2014
• Primary Completion: September 30, 2014
• Study Completion: July 1, 2016
• Last Updated: December 5, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)