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Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation

Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05217511
Enrollment
47
Registered
2022-02-01
Start date
2022-02-01
Completion date
2022-08-31
Last updated
2022-03-02

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

Conditions

Respiratory Insufficiency Requiring Mechanical Ventilation

Keywords

Diaphragm ultrasound, Intercostal muscle ultrasound

Brief summary

Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems caused by immobility. Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.No previous studies have shown whether training-specific respiratory muscles using an electrical stimulation can have overall benefits for ICU patients on MV.For this reason, the aim of this study was to evaluate, the effectiveness of the NMES therapy combined with early rehabilitation in the respiratory muscles of patients on MV.

Interventions

BEHAVIORALNeuromuscular Electrical Stimulation

NMES was performed using a portable machine.The negative electrodes were placed in the motor points of the following muscles: chest muscles (pectoralis major muscle fibres) and rectus abdominis muscles bilaterally. A second (positive) electrode was positioned distally to the first, at a site close to the muscle that was being electrically stimulated, totalling 1 channel with 2 electrodes for each muscle . Each NMES session lasted 30 min. The following parameters were used: 50 Hz frequency, pulse duration 300 ms, rise time 1 s, stimulus time (ON) 3 s, decay time 1 s, and relaxation time (OFF) 10 s. Intensity was increased until muscle contraction was visible or could be identified through palpation. In conscious patients, intensity was adjusted according to their tolerance.

Sponsors

The Affiliated Hospital of Qingdao University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Prolonged MV(\>72 h); * Written informed consent was obtained from the patients or their relatives

Exclusion criteria

* Previous neuromuscular disease; * Unrelieved pneumothorax, restricted diaphragmatic dyskinesia including abdominal high pressure, a large number of ascites * Thoracic or diaphragmatic malformation; * Local skin damage and infection; * Indwelling a temporary or permanent pacemaker; * Severe obesity(BMI\>35 kg/m2) * Various reasons (severe intestinal gas accumulation, structural abnormalities) lead to the failure of ultrasonic detection of diaphragm movement; * Patients with an expected survival time of less than 7 days or with palliative care

Design outcomes

Primary

MeasureTime frameDescription
diaphragmatic thickening fraction(DTF)baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubationDTF shows varied thickness of the diaphragm at end-expiration and end-inspiration. Te maximum and minimum values of each breathing cycle were taken as the end-inspiratory diaphragm thickness (DTei) and the end-expiratory diaphragm thickness (DTee), respectively. DTF was calculated by DTF=(DTei DTee)/DTee 100%. Te values for 3 consecutive respiratory cycles were recorded and the average value was taken as the fnal value

Secondary

MeasureTime frameDescription
Parasternal Intercostal Muscle Ultrasoundbaseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubationA 10- to 15-MHz linear array transducer was positioned perpendicular to the anterior thorax surface in the longitudinal scan, at the level of the second right intercostal space, approximately 6 to 8 cm lateral to the sternal edge with a window visualizing the second and third ribs. . Using M-mode, the ultrasound beam was perpendicularly directed at the midsection of the muscle, where it is the thinnest at end-expiration. The thickness of the parasternal intercostal muscle was measured on frozen images at end expiration and at peak inspiration.

Other

MeasureTime frame
ventilator-free days at 28 days28 days

Countries

China

Contacts

Primary ContactZehua Dong, Dr.
liuyingwallace@163.com86-0532-82919386

Outcome results

None listed

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