PolyneuropathyPhase 4NCT02033057
Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.
A Phase 4 study testing Muscular electrostimulation and percutaneus muscular biopsy. in people with Polyneuropathy, run by Hospital Universitario La Fe at 1 site in Spain.
Trial summary
Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or neuropathy which difficulties both the process of extubation and the functional recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyneuropathy
- What is being tested?
- Muscular electrostimulation and percutaneus muscular biopsy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2012to Oct 2014
- Phase
- Phase 4
- 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
- Patients older than 18 years.
- Sedated and mechanically ventilated critically ill patients, more than 48 hours.
Who cannot join
- Body mass index > 45 or < 20 kg/m2.
- Pregnant.
- Epilepsia.
- Use muscular blocks.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politécnico La Fe.
Valencia, Valencia, 46026
Paula Ramirez, 0034619031958
Paula Rami-rez
About this study
Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or neuropathy which difficulties both the process of extubation and the functional recovery. The objective of this project is to analyze the effect of muscle electrostimulation (ESM) on muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a single center, prospective, randomized trial to be held in the ICU of " Universitarian hospital La Fe" in collaboration with the service of Neurophysiology of the hospital. All patients undergoing sedation and mechanical ventilation (with an expected duration longer than 48h) and without any of the exclusion criteria detailed in the Methodology section will be included in the study. The intervention will consist of a muscular electrostimulation with the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle groups (5 per side) following established protocols, at least 5 days a week. We will evaluate muscle strength by Medical Research Council scale, functional capacity by Barthel scale and Neurophaty Disability Scale, all clinical events will be collected and electrophysiologic, echographic and histologic parameters will be measured. The process of extubation will be performed following an established protocol, the duration will be collected as the same manner as ICU.
- Conditions
- Polyneuropathy
- Being tested
- Muscular electrostimulation and percutaneus muscular biopsy.
- Keywords
- Muscular electrostimulation, mechanically ventilated, critically ill patients, muscular weakness.
- Medical subject headings
- Polyneuropathies, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscular electrostimulation and percutaneus muscular biopsy.Procedure or surgery
Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.
| Study group | Role | What they receive |
|---|---|---|
| Muscular electrostimulation. | Experimental | The interventions is muscular electrostimulation. Receives: Procedure: Muscular electrostimulation and percutaneus muscular biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscular weakness
We measure the muscular weakness, with the medical research council scale.
Measured: at the time of weaning, 30 days after extubation and one year after extubation.
Secondary outcomes (1)
time of weaning
Measured: everyday
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startOct 2012
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Ramirez, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033057
- Sponsor's protocol ID
- Pi12/01018
- Status last verified
- Oct 2012
- First submitted
- 8 Jan 2014
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.
- ClinicalTrials.gov ID
- NCT02033057
- Acronym / sponsor ID
- Pi12/01018
- Conditions
- Polyneuropathy
- Keywords
- Muscular electrostimulation, mechanically ventilated, critically ill patients, muscular weakness.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 10 Jan 2014 (estimated)
- 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.
Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or neuropathy which difficulties both the process of extubation and the functional recovery. The objective of this project is to analyze the effect of muscle electrostimulation (ESM) on muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a single center, prospective, randomized trial to be held in the ICU of " Universitarian hospital La Fe" in collaboration with the service of Neurophysiology of the hospital. All patients undergoing sedation and mechanical ventilation (with an expected duration longer than 48h) and without any of the exclusion criteria detailed in the Methodology section will be included in the study. The intervention will consist of a muscular electrostimulation with the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle groups (5 per side) following established protocols, at least 5 days a week. We will evaluate muscle strength by Medical Research Council scale, functional capacity by Barthel scale and Neurophaty Disability Scale, all clinical events will be collected and electrophysiologic, echographic and histologic parameters will be measured. The process of extubation will be performed following an established protocol, the duration will be collected as the same manner as ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscular electrostimulation. | Experimental | Procedure: Muscular electrostimulation and percutaneus muscular biopsy.The interventions is muscular electrostimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 18 years.
- Sedated and mechanically ventilated critically ill patients, more than 48 hours.
Key exclusion criteria (4 listed)
- Body mass index > 45 or < 20 kg/m2.
- Pregnant.
- Epilepsia.
- Use muscular blocks.
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 |
|---|---|---|
| Muscular electrostimulation and percutaneus muscular biopsy.Muscular electrostimulation everyday and percutaneus muscular biopsy weekly. | Procedure or surgery | Muscular electrostimulation. |
Primary outcome
muscular weakness
Time frame: at the time of weaning, 30 days after extubation and one year after extubation.
We measure the muscular weakness, with the medical research council scale.
1 secondary outcome
time of weaning
Time frame: everyday
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Muscular electrostimulation and percutaneus muscular biopsy. in people with Polyneuropathy, run by Hospital Universitario La Fe at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Jan 2014. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscular weakness (time frame: at the time of weaning, 30 days after extubation and one year after extubation.). 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 10 Jan 2014.