Prolonged Mechanical VentilationNMESNCT04076475
Neuromuscular Electrical Stimulation in Patients With Prolonged Mechanical Ventilation
A study testing neuromuscular electrical stimulation in people with Prolonged Mechanical Ventilation, run by Chang Gung University at 2 sites in Taiwan.
Trial summary
Prolonged mechanical ventilation has been defined as the need for >21 days. The muscle weakness occurred most commonly in patients with PMV and resulted in increasing time to wean from mechanical ventilation, and longer stay in hospital. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Prolonged Mechanical Ventilation
- 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
- 8 participants
- Where
- 2 sitesTaiwan
- Study dates
- 25 Feb 2019to 31 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≧ 20 years;
- MV for > 6 h/day for > 21 days; and
- medical stability, absence of signs and symptoms of infection, and hemodynamic stability).
- hemodynamic stable without or with a low dose of vasopressor ((Dopamine or Dobutamine <5μg/kg/min)
Who cannot join
- acute lung or systemic infection,
- ongoing neuromuscular disease (e.g., myasthenia gravis, Guillain-Barre disease)
- bone contracture or skin lesion
- obesity [body mass index (BMI) >35 kg/m2].
- disease at end-stage with expecting survival <=6month
- pregnancy
- severe edema (deep indentation when pressing a finger into the skin, requiring >30 s to rebound
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Dept of Respiratory therapy, Chang Gung University
Taoyuan, 333
Chang Gung University
Taoyuan City, 333
About this study
Official title: Effects of Neuromuscular Electrical Stimulation on Patients With Prolonged Mechanical Ventilation
Prolonged mechanical ventilation has been defined as the need for >21 days. The muscle weakness occurred most commonly in patients with PMV and resulted in increasing time to wean from mechanical ventilation, and longer stay in hospital.
Neuromuscular electrical stimulation (NMES) involves applying a stimuli to skeletal muscle, to trigger muscle contraction, and it can be used for the recovery of muscle mass and muscle strength following prolonged immobilization. NMES also improve microcirculation and systemic circulation in patients with cardiopulmonary diseases.
Read more
The purposes of this study:
- to examine the acute effects of NMES on the microcirculation, physiologic response and metabolic demand in patients with PMV.
- to investigate the training effects of NMES on microcirculation, muscle strength and weaning outcomes in patients with PMV.
METHODS: Subjects with PMV are recruited and are randomly assigned into NMES (n=20) or control group (n=20).The NMES group receive daily NMES for 30 min/session for 10 days. The assessment of muscle strength and weaning profile were performed before and after intervention. During the first and the last NMES session, the status of microcirculation and local muscle tissue oxygenation will be measured by NIRS, and the metabolic status will be measured by IC. The ventilator weaning rate and length of stay in RCC will be recorded.
Read the detailed description
Scientific and technologic advances in medicine have resulted in the ability of the medical team to prolong life. One consequence of life-extending advancements in technology is the increasing numbers of patients requiring prolonged mechanical ventilation (PMV). Prolonged mechanical ventilation has been defined as the need for 21 days, of consecutive mechanical ventilation for six hours/day. The interaction of underlying diseases and prolong bedridden result in various complication in patients with PMV. Known complications can include: muscle weakness, atelectasis, and deconditioning. The muscle weakness occurred most commonly in patients with PMV and resulted in increasing time to wean successfully from mechanical ventilation, and longer stay in hospital. Exercise is effective in improving muscle strength and physical function in patients with heart failure and chronic obstructive pulmonary disease (COPD. However, patients with PMV may be too fragile to perform excise. Neuromuscular electrical stimulation (NMES) involves applying a series of stimuli to skeletal muscle, primarily to trigger muscle contraction, and it can be used for the recovery of muscle mass and muscle strength following prolonged immobilization. NMES also improve microcirculation and systemic circulation in patients with cardiopulmonary diseases. In addition, the application of NMES increases oxygen consumption of whole body and elicits physiologic effects that are similar to aerobic exercise. However, the effects of NMES on the PMV population remain unclear. Near-infrared spectroscopy (NIRS) is a recently developed noninvasive method of measuring tissue oxygenation, blood flow, and local tissue metabolism. NIRS combined with a vascular occlusion test is proposed as a tool to assess the microvascular response. Indirect calorimetry (IC) uses the method of breath-bybreath monitoring by pneumotachography to measure oxygen consumption (VO2) and carbon dioxide production (VCO2).
The purposes of this study:
- to examine the acute effects of NMES on the microcirculation, physiologic response and metabolic demand in patients with PMV.
- to investigate the training effects of NMES on microcirculation, muscle strength and weaning outcomes in patients with PMV. METHODS: Subjects who have been on ventilator for>= 21 days are recruited form respiratory care center (RCC) and are randomly assigned into NMES (n=20) or control group (n=20).The NMES group receive daily NMES for 30 min/session for 10 days. The assessment of muscle strength and weaning profile were performed before and after intervention. During the first and the last NMES session, the status of microcirculation and local muscle tissue oxygenation will be measured by NIRS, and the metabolic status will be measured by IC. The mechanical ventilator weaning outcomes and length of stay in RCC will be recorded. The results of this study help us to confirm whether the application of NMES is beneficial in the improvement of muscle strength in patients with PMV, and to furtherly understand the mechanisms. The results may provide an alternative options for clinicians functional and hospitalization outcomes in patients with PMV.
- Conditions
- Prolonged Mechanical Ventilation
- Being tested
- neuromuscular electrical stimulation
- Keywords
- neuromuscular electrical stimulation, tissue oxygenation, prolonged mechanical ventilation, metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulationDevice
Participants will receive muscular electrical stimulation on quadriceps muscle and abdominal muscles for 30 min/day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| electrical stimulation | Experimental | receive daily NMES for 30 min/session for 10 days. Receives: Device: neuromuscular electrical stimulation |
| Control | Sham comparator | receive similar electrical stimulation (ES) procedure as those in the intervention group but with ES machine power off. Receives: Device: neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue oxygenation
local muscle tissue oxygenation
Measured: the 1st day of intervention
tissue oxygenation
local muscle tissue oxygenation
Measured: the 10th day of intervention
muscle strength
Medical research council score. The score ranges from a 0 points (zero strength) to 5 points (good)
Measured: the 1st day of intervention
muscle strength
Medical research council score. The score ranges from a 0 points (zero strength) to 5 points (good).
Measured: the 10th day of intervention
pulmonary function (maximal inspiratory pressure)
pressure gauge
Measured: the 1st day of intervention
pulmonary function (maximal inspiratory pressure)
pressure gauge
Measured: the 10th day of intervention
oxygen consumption
the amount of oxygen that body consume, is measured by indirect calorimetry
Measured: the 1st day of intervention
oxygen consumption
the amount of oxygen that body consume, is measured by indirect calorimetry
Measured: the 10th day of intervention
energy expenditure (calories)
the amount of energy expenditure which is measured by indirect calorimetry
Measured: the 1st day of intervention
energy expenditure (calories)
the amount of energy expenditure which is measured by indirect calorimetry
Measured: the 10th day of intervention
pulmonary function (rapid shallow breathing index)
respiratory rate/tidal volume
Measured: the 1st day of intervention
pulmonary function (rapid shallow breathing index)
respiratory rate/tidal volume
Measured: the 10th day of intervention
Secondary outcomes (2)
weaning rate
ventilator weaning results (weaning successful/failure)
Measured: through study completion, an maximal 42 days
length of stay in respiratory care center
the total days of stay in respiratory care center
Measured: through study completion, an maximal 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start25 Feb 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Mechanical VentilationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Chen Yen-Huey, Chang Gung University
- Investigators
- Yen-Huey Chen, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076475
- Sponsor's protocol ID
- 201802160A3
- Acronym
- NMES
- Status last verified
- Feb 2021
- First submitted
- 29 Aug 2019
- Last updated
- 28 Jul 2021
- 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 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation on Patients With Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04076475
- Acronym / sponsor ID
- NMES / 201802160A3
- Conditions
- Prolonged Mechanical Ventilation
- Keywords
- neuromuscular electrical stimulation, tissue oxygenation, prolonged mechanical ventilation, metabolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 3 Sep 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.
Prolonged mechanical ventilation has been defined as the need for >21 days. The muscle weakness occurred most commonly in patients with PMV and resulted in increasing time to wean from mechanical ventilation, and longer stay in hospital.
Neuromuscular electrical stimulation (NMES) involves applying a stimuli to skeletal muscle, to trigger muscle contraction, and it can be used for the recovery of muscle mass and muscle strength following prolonged immobilization. NMES also improve microcirculation and systemic circulation in patients with cardiopulmonary diseases.
The purposes of this study:
- to examine the acute effects of NMES on the microcirculation, physiologic response and metabolic demand in patients with PMV.
- to investigate the training effects of NMES on microcirculation, muscle strength and weaning outcomes in patients with PMV.
METHODS: Subjects with PMV are recruited and are randomly assigned into NMES (n=20) or control group (n=20).The NMES group receive daily NMES for 30 min/session for 10 days. The assessment of muscle strength and weaning profile were performed before and after intervention. During the first and the last NMES session, the status of microcirculation and local muscle tissue oxygenation will be measured by NIRS, and the metabolic status will be measured by IC. The ventilator weaning rate and length of stay in RCC will be recorded.
Detailed description
Scientific and technologic advances in medicine have resulted in the ability of the medical team to prolong life. One consequence of life-extending advancements in technology is the increasing numbers of patients requiring prolonged mechanical ventilation (PMV). Prolonged mechanical ventilation has been defined as the need for 21 days, of consecutive mechanical ventilation for six hours/day. The interaction of underlying diseases and prolong bedridden result in various complication in patients with PMV. Known complications can include: muscle weakness, atelectasis, and deconditioning. The muscle weakness occurred most commonly in patients with PMV and resulted in increasing time to wean successfully from mechanical ventilation, and longer stay in hospital. Exercise is effective in improving muscle strength and physical function in patients with heart failure and chronic obstructive pulmonary disease (COPD. However, patients with PMV may be too fragile to perform excise. Neuromuscular electrical stimulation (NMES) involves applying a series of stimuli to skeletal muscle, primarily to trigger muscle contraction, and it can be used for the recovery of muscle mass and muscle strength following prolonged immobilization. NMES also improve microcirculation and systemic circulation in patients with cardiopulmonary diseases. In addition, the application of NMES increases oxygen consumption of whole body and elicits physiologic effects that are similar to aerobic exercise. However, the effects of NMES on the PMV population remain unclear. Near-infrared spectroscopy (NIRS) is a recently developed noninvasive method of measuring tissue oxygenation, blood flow, and local tissue metabolism. NIRS combined with a vascular occlusion test is proposed as a tool to assess the microvascular response. Indirect calorimetry (IC) uses the method of breath-bybreath monitoring by pneumotachography to measure oxygen consumption (VO2) and carbon dioxide production (VCO2).
The purposes of this study:
- to examine the acute effects of NMES on the microcirculation, physiologic response and metabolic demand in patients with PMV.
- to investigate the training effects of NMES on microcirculation, muscle strength and weaning outcomes in patients with PMV. METHODS: Subjects who have been on ventilator for>= 21 days are recruited form respiratory care center (RCC) and are randomly assigned into NMES (n=20) or control group (n=20).The NMES group receive daily NMES for 30 min/session for 10 days. The assessment of muscle strength and weaning profile were performed before and after intervention. During the first and the last NMES session, the status of microcirculation and local muscle tissue oxygenation will be measured by NIRS, and the metabolic status will be measured by IC. The mechanical ventilator weaning outcomes and length of stay in RCC will be recorded. The results of this study help us to confirm whether the application of NMES is beneficial in the improvement of muscle strength in patients with PMV, and to furtherly understand the mechanisms. The results may provide an alternative options for clinicians functional and hospitalization outcomes in patients with PMV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrical stimulation | Experimental | Device: neuromuscular electrical stimulationreceive daily NMES for 30 min/session for 10 days. |
| Control | Sham comparator | Device: neuromuscular electrical stimulationreceive similar electrical stimulation (ES) procedure as those in the intervention group but with ES machine power off. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≧ 20 years;
- MV for > 6 h/day for > 21 days; and
- medical stability, absence of signs and symptoms of infection, and hemodynamic stability).
- hemodynamic stable without or with a low dose of vasopressor ((Dopamine or Dobutamine <5μg/kg/min)
Key exclusion criteria (7 listed)
- acute lung or systemic infection,
- ongoing neuromuscular disease (e.g., myasthenia gravis, Guillain-Barre disease)
- bone contracture or skin lesion
- obesity [body mass index (BMI) >35 kg/m2].
- disease at end-stage with expecting survival <=6month
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 stimulationParticipants will receive muscular electrical stimulation on quadriceps muscle and abdominal muscles for 30 min/day for 10 days | Device | Control, electrical stimulation |
Primary outcome
tissue oxygenation
Time frame: the 1st day of intervention
local muscle tissue oxygenation
tissue oxygenation
Time frame: the 10th day of intervention
local muscle tissue oxygenation
muscle strength
Time frame: the 1st day of intervention
Medical research council score. The score ranges from a 0 points (zero strength) to 5 points (good)
muscle strength
Time frame: the 10th day of intervention
Medical research council score. The score ranges from a 0 points (zero strength) to 5 points (good).
pulmonary function (maximal inspiratory pressure)
Time frame: the 1st day of intervention
pressure gauge
pulmonary function (maximal inspiratory pressure)
Time frame: the 10th day of intervention
pressure gauge
oxygen consumption
Time frame: the 1st day of intervention
the amount of oxygen that body consume, is measured by indirect calorimetry
oxygen consumption
Time frame: the 10th day of intervention
the amount of oxygen that body consume, is measured by indirect calorimetry
energy expenditure (calories)
Time frame: the 1st day of intervention
the amount of energy expenditure which is measured by indirect calorimetry
energy expenditure (calories)
Time frame: the 10th day of intervention
the amount of energy expenditure which is measured by indirect calorimetry
pulmonary function (rapid shallow breathing index)
Time frame: the 1st day of intervention
respiratory rate/tidal volume
pulmonary function (rapid shallow breathing index)
Time frame: the 10th day of intervention
respiratory rate/tidal volume
2 secondary outcomes
weaning rate
Time frame: through study completion, an maximal 42 days
length of stay in respiratory care center
Time frame: through study completion, an maximal 42 days
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 28 Jul 2021.
- 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.
Yen-Huey Chen, PhD principal investigator
Chang Gung University
2 sites 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 Prolonged Mechanical Ventilation, run by Chang Gung University at 2 sites in Taiwan.
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 4 inclusion and 7 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
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?
tissue oxygenation (time frame: the 1st day of intervention). The study lists 12 primary outcomes in all. 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 28 Jul 2021.