Clinical trial NCT04281810: Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients
Official title: Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Function in Patients With Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Keywords: electrical stimulation
diaphragmatic
weaning
respiratory muscle
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Acute lung or systemic infection, hemodynamic instability, patients with pacemakers, abdominal distention, and pregnancy.

Primary outcomes:
measure: tidal volume
timeFrame: 1st day of intervention
measure: tidal volume
timeFrame: through study completion,an average of 4 weeks
measure: rapid shallow breathing index
timeFrame: 1st day of intervention
measure: rapid shallow breathing index
timeFrame: through study completion,an average of 4 weeks
measure: respiratory muscle strength (maximal inspiratory pressure)
timeFrame: the 1st day of intervention
measure: respiratory muscle strength (maximal expiratory pressure)
timeFrame: the 1st day of intervention
measure: respiratory muscle strength (maximal inspiratory pressure)
timeFrame: through study completion,an average of 4 weeks
measure: respiratory muscle strength (maximal expiratory pressure)
timeFrame: through study completion,an average of 4 weeks
Secondary outcomes:
measure: weaning rate
timeFrame: through study completion,an average of 7 weeks
measure: length of stay in respiratory care center
timeFrame: through study completion,an average of 7 weeks
Other outcomes:
Locations:
city: TaoYuan City
country: Taiwan
facility: Chang Gung University
state: Tao-Yuan
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yi-Fei Hsin
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung University
name: Yen-Huey Chen
role: STUDY_DIRECTOR
References: