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

Q

Qingdao University

Status

Unknown

Conditions

Respiratory Insufficiency Requiring Mechanical Ventilation

Treatments

Behavioral: Neuromuscular Electrical Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05217511
DZH20220104

Details and patient eligibility

About

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.

Enrollment

47 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

47 participants in 2 patient groups

NMSE Group
Experimental group
Description:
Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points starting on the first day of randomization.The subjects also receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.
Treatment:
Behavioral: Neuromuscular Electrical Stimulation
CPT group
No Intervention group
Description:
The subjects only receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.

Trial contacts and locations

1

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Central trial contact

Zehua Dong, Dr.

Data sourced from clinicaltrials.gov

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