Postoperative Coronary Artery Bypass Grafting (CABG)NCT00442728
The Effect of Neuromuscular Electrical Stimulation
A study testing ELECTRICAL STIMULATION in people with Postoperative Coronary Artery Bypass Grafting (CABG) and Chronic Obstructive Pulmonary Disease (COPD), run by Provinciale Hogeschool Limburg at 1 site in Belgium.
Trial summary
The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on intensive care was studied. The aim of this study was to explore if electrical stimulation could prevent muscle atrophy. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Postoperative Coronary Artery Bypass Grafting (CABG), Chronic Obstructive Pulmonary Disease (COPD), Ventilatory Failure
- What is being tested?
- ELECTRICAL STIMULATION
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2003to Jun 2003
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Prior to inclusion in the study, an informed consent was given by the family of the patients which was approved by the local Ethics Committee of the Virga Jesse Hospital and was performed in accordance with the standards of the 1964 Declaration of Helsinki.
Who cannot join
- Patients were excluded from the study if they were still able to move their limb actively in spite of the sedation. Patients were also excluded if they had signs of recent ischemia or infarction for less then seven days. Patients with severe orthopaedic or vascular damage, i.e., fractures or oedema in the lower limbs were also excluded. Patients with an augmented risk for neuro electrical stimulation such as open wounds, hemodialysis or an arterial catheter at the stimulation area were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study
The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on intensive care was studied. The aim of this study was to explore if electrical stimulation could prevent muscle atrophy.
Read the detailed description
Patients were included in the study one day after administration when prolonged sedation and ventilation were expected. They were divided into intervention (n=7) and control (n=14) groups. For the intervention group, an intermittent neuromuscular electrical stimulation was applied daily for 30 minutes on the right thigh whereas the left thigh was used as a control. Heart rate, respiration rate, systolic and diastolic blood pressure and oxygen saturation were monitored before, during and after the electrostimulation. Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upper edge of the kneecap.
- Conditions
- Postoperative Coronary Artery Bypass Grafting (CABG), Chronic Obstructive Pulmonary Disease (COPD), Ventilatory Failure
- Being tested
- ELECTRICAL STIMULATION
- Keywords
- Functional electrical stimulation, muscular atrophy, intensive care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoventilation, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELECTRICAL STIMULATIONDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startJan 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Coronary Artery Bypass Grafting (CABG)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 21 participants
Sponsor and investigators
- Lead sponsor
- Provinciale Hogeschool Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Investigators
- RAf LJ Meesen, Phd, Principal investigator, PHL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442728
- Sponsor's protocol ID
- REVAL300107
- Status last verified
- Mar 2007
- First submitted
- 11 Feb 2007
- Last updated
- 2 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study
- ClinicalTrials.gov ID
- NCT00442728
- Acronym / sponsor ID
- REVAL300107
- Conditions
- Postoperative Coronary Artery Bypass Grafting (CABG), Chronic Obstructive Pulmonary Disease (COPD), Ventilatory Failure
- Keywords
- Functional electrical stimulation, muscular atrophy, intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants
- Lead sponsor
- Provinciale Hogeschool LimburgUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Jan 2003
- Study completion
- Jun 2003
- First posted
- 2 Mar 2007 (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.
The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on intensive care was studied. The aim of this study was to explore if electrical stimulation could prevent muscle atrophy.
Detailed description
Patients were included in the study one day after administration when prolonged sedation and ventilation were expected. They were divided into intervention (n=7) and control (n=14) groups. For the intervention group, an intermittent neuromuscular electrical stimulation was applied daily for 30 minutes on the right thigh whereas the left thigh was used as a control. Heart rate, respiration rate, systolic and diastolic blood pressure and oxygen saturation were monitored before, during and after the electrostimulation. Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upper edge of the kneecap.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- . Prior to inclusion in the study, an informed consent was given by the family of the patients which was approved by the local Ethics Committee of the Virga Jesse Hospital and was performed in accordance with the standards of the 1964 Declaration of Helsinki.
Key exclusion criteria (1 listed)
- Patients were excluded from the study if they were still able to move their limb actively in spite of the sedation. Patients were also excluded if they had signs of recent ischemia or infarction for less then seven days. Patients with severe orthopaedic or vascular damage, i.e., fractures or oedema in the lower limbs were also excluded. Patients with an augmented risk for neuro electrical stimulation such as open wounds, hemodialysis or an arterial catheter at the stimulation area were also excluded.
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 STIMULATION | Device | – |
Primary outcome
Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp
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 2 Mar 2007.
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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.
RAf LJ Meesen, Phd principal investigator
PHL
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 Postoperative Coronary Artery Bypass Grafting (CABG) and Chronic Obstructive Pulmonary Disease (COPD), run by Provinciale Hogeschool Limburg at 1 site in Belgium.
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 1 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 2 Mar 2007. 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 Belgium. 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?
Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp. 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 2 Mar 2007.