Critical CareNCT03815994
Neuromuscular Electrical Stimulation in Critically Ill Patients.
A study testing Neuromuscular Electrical Stimulation in people with Critical Care and Rehabilitation, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Critical Care, Rehabilitation
- What is being tested?
- Neuromuscular Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Nov 2018to 29 Jan 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients that will be admitted to the intensive care unit
- Hemodynamic stability
- Mechanical ventilation.
Who cannot join
- In general:
- a. Pregnant women
- b. Brain death
- c. Neuromuscular diseases
- d. Use of pre-existing neuromuscular blocker in the last 24 hours, prior to the study protocol.
- Contraindications for the use of NMES:
Show all 25Show fewer
- a. Fractures
- b. Burns
- c. Skin lesions
- d. Systemic vascular impairment diseases such as systemic lupus erythematosus, thromboembolic disease, deep vein thrombosis (which was not therapeutically anticoagulated for a time greater than 36 hours)
- e. Lower limb amputations
- f. Cardiac pacemaker,
- g. Thrombocytopenia less than 20,000/mm3
- h. BMI greater than 35 kg/m2
- i. Important lower extremity oedema
- j. Agitation and/or signs of pain during the electrical stimulation.
- Contraindications to begin or continue NMES procedure:
- a. Mean arterial blood pressure less than 65 mmHg
- b. Use of vasopressor >50% of themaximum dose (dopamine >12.5 μg/kg per minute; vasopressin >0.02U/min and norepinephrine >1 μg/kg per minute),
- c. Heart rate <50 or >140bpm
- d. Arrhythmias with hemodynamic consequences
- e. Myocardial ischemia,
- f. Temperature <34 or >39oC
- g. Intracranial pressure >20 cmH2O
- h. Decrease in 10% of SpO2 baseline value or <88% for more than one minute.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Critically Ill Patients: a Randomised Crossover Clinical Trial Protocol.
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients.
Read the detailed description
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. It will be a randomised crossover clinical trial. Thirty-one patients will enrolled. Patients will be selected, randomly, to the intervention Protocol (decubitus position with the limbs raised and NMES) and control (decubitus position with the limbs raised without NMES).The patients will be allocated in Group 1 (intervention and control) or group 2 (control and intervention) with a wash-out period of 4 to 6 hours between them.
The main outcome will be metabolic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.
The results of this study will allow better understanding of the metabolic effects of NMES in patients critically ill.
- Conditions
- Critical Care, Rehabilitation
- Being tested
- Neuromuscular Electrical Stimulation
- Keywords
- Physical therapy modalities,, Electric stimulation therapy, Indirect calorimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationDevice
Also called Functional Electrical Stimulation
This device produces a muscle contraction in response to a externally generated low-voltage electric impulse, which is conducted through electrodes placed on the skin over the muscle group to be stimulated.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: group 1 | Experimental | Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES. Receives: Device: Neuromuscular Electrical Stimulation |
| group 2 | Sham comparator | Decubitus Position with the limbs raised withou tNeuromuscular Electrical Stimulation and after Neuromuscular Electrical Stimulation. Receives: Device: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Oxygen consumption (VO2),from baseline and interventions.
Change of Oxygen consumption (VO2) will be evaluated by calorimetry
Measured: VO2 will be taken during the each intervention, it will be taken only the first day
Secondary outcomes (1)
Change of Carbon dioxide production (VCO2) from baseline and interventions.
Change of Carbon dioxide production (VCO2) will be evaluated by calorimetry
Measured: VCO2 will be taken during the each intervention, it will be taken only the first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start13 Nov 2018
- Primary completion6 Jan 2020
- Study completion29 Jan 2021 (estimated)
Why it stopped: This study had to be suspended due to COVID-19 Pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ada Clarice Gastaldi, University of Sao Paulo
- Investigators
- Ada C Gastaldi, PhD, Principal investigator, Ribeirao Preto Medicine School-University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815994
- Sponsor's protocol ID
- USP 2018-1
- Status last verified
- Feb 2021
- First submitted
- 13 Nov 2018
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification, will be available.
Publications
Lago AF, Basile-Filho A, de Oliveira AS, de Souza HCD, Dos Santos DO, Gastaldi AC. Effects of physical therapy with neuromuscular electrical stimulation in acute and late septic shock patients: A randomised crossover clinical trial. PLoS One. 2022 Feb 17;17(2):e0264068. doi: 10.1371/journal.pone.0264068. eCollection 2022.
PubMed 35176099
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Critically Ill Patients: a Randomised Crossover Clinical Trial Protocol.
- ClinicalTrials.gov ID
- NCT03815994
- Acronym / sponsor ID
- USP 2018-1
- Conditions
- Critical Care, Rehabilitation
- Keywords
- Physical therapy modalities,, Electric stimulation therapy, Indirect calorimetry
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: This study had to be suspended due to COVID-19 Pandemic.
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 29 Jan 2021 (estimated)
- First posted
- 25 Jan 2019 (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.
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients.
Detailed description
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. It will be a randomised crossover clinical trial. Thirty-one patients will enrolled. Patients will be selected, randomly, to the intervention Protocol (decubitus position with the limbs raised and NMES) and control (decubitus position with the limbs raised without NMES).The patients will be allocated in Group 1 (intervention and control) or group 2 (control and intervention) with a wash-out period of 4 to 6 hours between them.
The main outcome will be metabolic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.
The results of this study will allow better understanding of the metabolic effects of NMES in patients critically ill.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: group 1 | Experimental | Device: Neuromuscular Electrical StimulationNeuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES. |
| group 2 | Sham comparator | Device: Neuromuscular Electrical StimulationDecubitus Position with the limbs raised withou tNeuromuscular Electrical Stimulation and after Neuromuscular Electrical Stimulation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients that will be admitted to the intensive care unit
- Hemodynamic stability
- Mechanical ventilation.
Key exclusion criteria (25 listed)
- In general:
- Contraindications for the use of NMES:
- Contraindications to begin or continue NMES procedure:
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 |
|---|---|---|
| Neuromuscular Electrical StimulationAlso: Functional Electrical StimulationThis device produces a muscle contraction in response to a externally generated low-voltage electric impulse, which is conducted through electrodes placed on the skin over the muscle group to be stimulated. | Device | Experimental: group 1, group 2 |
Primary outcome
Change of Oxygen consumption (VO2),from baseline and interventions.
Time frame: VO2 will be taken during the each intervention, it will be taken only the first day
Change of Oxygen consumption (VO2) will be evaluated by calorimetry
1 secondary outcome
Change of Carbon dioxide production (VCO2) from baseline and interventions.
Time frame: VCO2 will be taken during the each intervention, it will be taken only the first day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 35176099Lago AF, Basile-Filho A, de Oliveira AS, de Souza HCD, Dos Santos DO, Gastaldi AC. Effects of physical therapy with neuromuscular electrical stimulation in acute and late septic shock patients: A randomised crossover clinical trial. PLoS One. 2022 Feb 17;17(2):e0264068. doi: 10.1371/journal.pone.0264068. eCollection 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, will be available.
Related trials for Critical Care
Not yet recruitingObservational study
Lactate/Albumin Ratio and Mortality in Respiratory Failure
Acute Respiratory Failure, Critical Illness
RecruitingObservational study
Respiratory Physiotherapy and Inflammatory Biomarkers in Critically Ill Patients With Pneumonia
Pneumonia, Critical Illness
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
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.
Ada C Gastaldi, PhD principal investigator
Ribeirao Preto Medicine School-University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation in people with Critical Care and Rehabilitation, run by University of Sao Paulo 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 3 inclusion and 25 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: paused, as of the sponsor's last update on 5 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change of Oxygen consumption (VO2),from baseline and interventions. (time frame: VO2 will be taken during the each intervention, it will be taken only the first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815994, which also lists 1 linked publication.
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 Feb 2021.