Critical Illness MyopathyNCT03352102
Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients
A study testing Electrical stimulation in people with Critical Illness Myopathy and Respiration, Artificial, run by Pericles Almeida Delfino Duarte at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Myopathy, Respiration, Artificial
- What is being tested?
- Electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2014to 1 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or more
- 24 hours of MV or more
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário do Oeste do Paraná
Cascavel, Paraná, 85806-470
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness Myopathy, Respiration, Artificial
- Being tested
- Electrical stimulation
- Keywords
- Electric Stimulation, Intensive Care Units, Mechanical Ventilation, Ventilator Weaning
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationProcedure or surgery
Neuromuscular electrical stimulation therapy was performed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU and Hospital length of stay
Length of stay (in days) in ICU and in hospitalization
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Jan 2014
- Primary completion30 Sep 2014
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness MyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pericles Almeida Delfino Duarte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pericles Almeida Delfino Duarte, Universidade Estadual do Oeste do Paraná
- Investigators
- Pericles Duarte, Principal investigator, Hospital Universitário do Oeste do Parana, Universidade Estadual do Oeste do Parana.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352102
- Sponsor's protocol ID
- 134673
- Status last verified
- Dec 2017
- First submitted
- 20 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients: a Pilot Study.
- ClinicalTrials.gov ID
- NCT03352102
- Acronym / sponsor ID
- 134673
- Conditions
- Critical Illness Myopathy, Respiration, Artificial
- Keywords
- Electric Stimulation, Intensive Care Units, Mechanical Ventilation, Ventilator Weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pericles Almeida Delfino DuarteUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diaphragm Group (DG) | Experimental | Procedure: Electrical stimulationsubjects who received conventional physical therapy once a day, plus a daily session of electrical stimulation in the diaphragm. Intervention: Electrical stimulation of the diaphragm. |
| Quadriceps Group (QG) | Active comparator | Procedure: Electrical stimulationsubjects 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18 years or more
- 24 hours of MV or more
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulationNeuromuscular electrical stimulation therapy was performed | Procedure or surgery | Diaphragm Group (DG), Quadriceps Group (QG) |
Primary outcome
ICU and Hospital length of stay
Time frame: 60 days
Length of stay (in days) in ICU and in hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pericles Duarte principal investigator
Hospital Universitário do Oeste do Parana, Universidade Estadual do Oeste do Parana.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation in people with Critical Illness Myopathy and Respiration, Artificial, run by Pericles Almeida Delfino Duarte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU and Hospital length of stay (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.