TEDS in Prolonged Mechanical Ventilation

Effect of Transcutaneous Electrical Diaphragmatic Stimulation in Prolonged Mechanical Ventilation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04741724

Acronym

TEDS

Enrollment

Registered

2021-02-05

Start date

2017-07-01

Completion date

2019-03-01

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation

Keywords

electrical stimulation, diaphragmatic, weaning

Brief 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. 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.

Interventions

DEVICETEDS

An non-invasive intervention. During the intervention, the electrode was placed on the skin stimulated muscle.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

Healthy volunteers

Inclusion criteria

1. age ≥ 20 years; 2. MV for \> 6 h/day for \> 21 days; 3. medical stability

Exclusion criteria

1. acute lung or systemic infection, 2. hemodynamic instability, 3. abdominal distention, 4. pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
breathing frequency	through study completion, an average of 2 weeks	The pulmonary function as assessed by the measurement of respiratory rate
Pimax	through study completion, an average of 2 weeks	The pulmonary function as assessed by the measurement of max inspiratory pressure
Vt	through study completion, an average of 2 weeks	The pulmonary function as assessed by the measurement of tidal volume

Secondary

Measure	Time frame	Description
RCC days	through study completion, an average of 6 weeks	The total days that participants stay in the respiratory care center
weaning rate	through study completion, an average of 6 weeks	the status of ventilator use

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026