Mechanical VentilationTEDSNCT04741724
TEDS in Prolonged Mechanical Ventilation
A study testing TEDS in people with Mechanical Ventilation, run by Chang Gung University 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 to 100 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- TEDS
- 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
- 1 Jul 2017to 1 Mar 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 to 100 years
- 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
Who cannot join
- acute lung or systemic infection,
- hemodynamic instability,
- abdominal distention,
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Electrical Diaphragmatic Stimulation in 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
Subjects on ventilation for ≥21 days were randomly assigned to TEDS or control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters 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
- TEDS
- Keywords
- electrical stimulation, diaphragmatic, weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEDSDevice
Also called transcutaneous electrical diaphragmatic stimulation
An non-invasive intervention. During the intervention, the electrode was placed on the skin stimulated muscle.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous electrical diaphragmatic stimulation (TEDS) | Experimental | Subjects received daily TEDS (30min/day, 5days/week ) until the end of the weaning trial.
During TEDS, rectangular electrodes were placed on the parasternal region beside the xiphoid process; the sixth and seventh intercostal spaces in line with the mid-axillary line. TEDS was performed by applying biphasic waves at a stimulation frequency of 30 Hz, pulse width of 400 μs. TEDS intensity was gradually increased until visible muscle contraction was observed. Each session lasts for 30 min day. Receives: Device: TEDS |
| Control group | No intervention | Subjects in the control group did not received TEDS program. Subjects in the control group received the same pre- and post-measurement as those in TEDS group. The control group received medical treatment as those in TEDS group. The pulmonary function was measured at the beginning and end of the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
breathing frequency
The pulmonary function as assessed by the measurement of respiratory rate
Measured: through study completion, an average of 2 weeks
Pimax
The pulmonary function as assessed by the measurement of max inspiratory pressure
Measured: through study completion, an average of 2 weeks
Vt
The pulmonary function as assessed by the measurement of tidal volume
Measured: through study completion, an average of 2 weeks
Secondary outcomes (2)
RCC days
The total days that participants stay in the respiratory care center
Measured: through study completion, an average of 6 weeks
weaning rate
the status of ventilator use
Measured: through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Jul 2017
- Primary completion31 Dec 2018
- Study completion1 Mar 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.
- 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
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Yen-Huey, Chang Gung University
- Investigators
- Yen-Huey Chen, PhD, Study director, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741724
- Sponsor's protocol ID
- 201700096A3
- Acronym
- TEDS
- Status last verified
- Aug 2023
- First submitted
- 2 Feb 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Diaphragmatic Stimulation in Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04741724
- Acronym / sponsor ID
- TEDS / 201700096A3
- Conditions
- Mechanical Ventilation
- Keywords
- electrical stimulation, diaphragmatic, weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 5 Feb 2021 (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
Subjects on ventilation for ≥21 days were randomly assigned to TEDS or control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous electrical diaphragmatic stimulation (TEDS) | Experimental | Device: TEDSSubjects received daily TEDS (30min/day, 5days/week ) until the end of the weaning trial. During TEDS, rectangular electrodes were placed on the parasternal region beside the xiphoid process; the sixth and seventh intercostal spaces in line with the mid-axillary line. TEDS was performed by applying biphasic waves at a stimulation frequency of 30 Hz, pulse width of 400 μs. TEDS intensity was gradually increased until visible muscle contraction was observed. Each session lasts for 30 min day. |
| Control group | No intervention | –Subjects in the control group did not received TEDS program. Subjects in the control group received the same pre- and post-measurement as those in TEDS group. The control group received medical treatment as those in TEDS group. The pulmonary function was measured at the beginning and end of the intervention. |
Who may qualify
- Ages
- 20 to 100 years
- 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
Key exclusion criteria (4 listed)
- acute lung or systemic infection,
- hemodynamic instability,
- abdominal distention,
- 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 |
|---|---|---|
| TEDSAlso: transcutaneous electrical diaphragmatic stimulationAn non-invasive intervention. During the intervention, the electrode was placed on the skin stimulated muscle. | Device | transcutaneous electrical diaphragmatic stimulation (TEDS) |
Primary outcome
breathing frequency
Time frame: through study completion, an average of 2 weeks
The pulmonary function as assessed by the measurement of respiratory rate
Pimax
Time frame: through study completion, an average of 2 weeks
The pulmonary function as assessed by the measurement of max inspiratory pressure
Vt
Time frame: through study completion, an average of 2 weeks
The pulmonary function as assessed by the measurement of tidal volume
2 secondary outcomes
RCC days
Time frame: through study completion, an average of 6 weeks
weaning rate
Time frame: through study completion, an average of 6 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 30 Aug 2023.
Related trials for Mechanical Ventilation
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
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Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
Mechanically Ventilated Patients, Acute Respiratory Failure (ARF)
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Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
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Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
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 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 TEDS in people with Mechanical Ventilation, run by Chang Gung University 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 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: finished, as of the sponsor's last update on 30 Aug 2023. 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?
breathing frequency (time frame: through study completion, an average of 2 weeks). The study lists 3 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 30 Aug 2023.