Mechanical VentilationNCT04281810
Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients
A study testing transcutaneous electric diaphragm stimulation in people with Mechanical Ventilation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Muscle atrophy and diaphragm dysfunction are common with prolonged mechanical ventilation (PMV). Electrical stimulation has been shown to be beneficial in severe chronic heart failure and chronic obstructive pulmonary disease. However, its effect on PMV is unclear. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- transcutaneous electric diaphragm stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Apr 2017to 25 Jul 2019
- 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;
- Medical stability (PaO2 ≥ 60 mmHg at 40% FiO2, absence of signs and symptoms of infection, and hemodynamic stability).
Who cannot join
- Acute lung or systemic infection, hemodynamic instability, patients with pacemakers, abdominal distention, and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Function in Patients With Prolonged Mechanical Ventilation
Muscle atrophy and diaphragm dysfunction are common with prolonged mechanical ventilation (PMV). Electrical stimulation has been shown to be beneficial in severe chronic heart failure and chronic obstructive pulmonary disease. However, its effect on PMV is unclear. This study examined the effects of transcutaneous electrical diaphragmatic stimulation (TEDS) on respiratory muscle strength and weaning outcomes in patients with PMV.
Read the detailed description
Patients on ventilation for ≥21 days were randomly assigned to TEDS and control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters (tidal volume, respiratory rate, and rapid shallow breathing index) and respiratory muscle strength (Pimax, Pemax) were assessed. The hospitalization outcome, including weaning rate and length of stay, was followed up until discharge.
- Conditions
- Mechanical Ventilation
- Being tested
- transcutaneous electric diaphragm stimulation
- Keywords
- electrical stimulation, diaphragmatic, weaning, respiratory muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electric diaphragm stimulationDevice
The electrodes were placed on the parasternal region beside the xiphoid process; and the sixth and seventh intercostal spaces in line with the mid-axillary line. TEDS was set as biphasic waves, frequency of 30 Hz, pulse width of 400 μs, and rise time of 0.7s.
| Study group | Role | What they receive |
|---|---|---|
| TEDS | Experimental | Subjects received transcutaneous electrical diaphragm stimulation (TEDS) for 30min/ day till the end of the weaning trial Receives: Device: transcutaneous electric diaphragm stimulation |
| Control | No intervention | Subjects received similar medical treatment except for the TEDS program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
tidal volume
The tidal volume was measured by a spirometer
Measured: 1st day of intervention
tidal volume
The tidal volume was measured by a spirometer
Measured: through study completion,an average of 4 weeks
rapid shallow breathing index
respiratory rate/tidal volume
Measured: 1st day of intervention
rapid shallow breathing index
respiratory rate/tidal volume
Measured: through study completion,an average of 4 weeks
respiratory muscle strength (maximal inspiratory pressure)
pressure gauge
Measured: the 1st day of intervention
respiratory muscle strength (maximal expiratory pressure)
pressure gauge
Measured: the 1st day of intervention
respiratory muscle strength (maximal inspiratory pressure)
pressure gauge
Measured: through study completion,an average of 4 weeks
respiratory muscle strength (maximal expiratory pressure)
pressure gauge
Measured: through study completion,an average of 4 weeks
Secondary outcomes (2)
weaning rate
ventilator weaning results (weaning successful/failure)
Measured: through study completion,an average of 7 weeks
length of stay in respiratory care center
the total days of stay in respiratory care center
Measured: through study completion,an average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start20 Apr 2017
- Primary completion29 Sep 2018
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Fei Hsin, Principal investigator, Chang Gung Memorial HospitalYen-Huey Chen, Study director, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281810
- Sponsor's protocol ID
- 201700096A3D001
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 24 Feb 2020
- 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 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Function in Patients With Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04281810
- Acronym / sponsor ID
- 201700096A3D001
- Conditions
- Mechanical Ventilation
- Keywords
- electrical stimulation, diaphragmatic, weaning, respiratory muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 29 Sep 2018 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 24 Feb 2020 (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.
Muscle atrophy and diaphragm dysfunction are common with prolonged mechanical ventilation (PMV). Electrical stimulation has been shown to be beneficial in severe chronic heart failure and chronic obstructive pulmonary disease. However, its effect on PMV is unclear. This study examined the effects of transcutaneous electrical diaphragmatic stimulation (TEDS) on respiratory muscle strength and weaning outcomes in patients with PMV.
Detailed description
Patients on ventilation for ≥21 days were randomly assigned to TEDS and control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters (tidal volume, respiratory rate, and rapid shallow breathing index) and respiratory muscle strength (Pimax, Pemax) were assessed. The hospitalization outcome, including weaning rate and length of stay, was followed up until discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEDS | Experimental | Device: transcutaneous electric diaphragm stimulationSubjects received transcutaneous electrical diaphragm stimulation (TEDS) for 30min/ day till the end of the weaning trial |
| Control | No intervention | –Subjects received similar medical treatment except for the TEDS program. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 20 years;
- MV for > 6 h/day for > 21 days;
- Medical stability (PaO2 ≥ 60 mmHg at 40% FiO2, absence of signs and symptoms of infection, and hemodynamic stability).
Key exclusion criteria (1 listed)
- Acute lung or systemic infection, hemodynamic instability, patients with pacemakers, abdominal distention, and pregnancy.
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 |
|---|---|---|
| transcutaneous electric diaphragm stimulationThe electrodes were placed on the parasternal region beside the xiphoid process; and the sixth and seventh intercostal spaces in line with the mid-axillary line. TEDS was set as biphasic waves, frequency of 30 Hz, pulse width of 400 μs, and rise time of 0.7s. | Device | TEDS |
Primary outcome
tidal volume
Time frame: 1st day of intervention
The tidal volume was measured by a spirometer
tidal volume
Time frame: through study completion,an average of 4 weeks
The tidal volume was measured by a spirometer
rapid shallow breathing index
Time frame: 1st day of intervention
respiratory rate/tidal volume
rapid shallow breathing index
Time frame: through study completion,an average of 4 weeks
respiratory rate/tidal volume
respiratory muscle strength (maximal inspiratory pressure)
Time frame: the 1st day of intervention
pressure gauge
respiratory muscle strength (maximal expiratory pressure)
Time frame: the 1st day of intervention
pressure gauge
respiratory muscle strength (maximal inspiratory pressure)
Time frame: through study completion,an average of 4 weeks
pressure gauge
respiratory muscle strength (maximal expiratory pressure)
Time frame: through study completion,an average of 4 weeks
pressure gauge
2 secondary outcomes
weaning rate
Time frame: through study completion,an average of 7 weeks
length of stay in respiratory care center
Time frame: through study completion,an average of 7 weeks
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 24 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation
RecruitingObservational study
Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
Respiratory Acidosis in ICU Patients, Right Ventricular (RV) Dysfunction
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruitingObservational study
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
Humidifier Lung, Mechanical Fragility
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Active, not recruiting
Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients
Cardiac Surgery, Mechanical Ventilation After Surgery
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.
Yi-Fei Hsin principal investigator
Chang Gung Memorial Hospital
Yen-Huey Chen study director
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electric diaphragm stimulation in people with Mechanical Ventilation, run by Chang Gung Memorial Hospital at 1 site 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 3 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 24 Feb 2020. 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 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. 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?
tidal volume (time frame: 1st day of intervention). The study lists 8 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 24 Feb 2020.