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Clinical Trials/NCT05217511
NCT05217511
Unknown
Not Applicable

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

The Affiliated Hospital of Qingdao University1 site in 1 country47 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Insufficiency Requiring Mechanical Ventilation
Sponsor
The Affiliated Hospital of Qingdao University
Enrollment
47
Locations
1
Primary Endpoint
diaphragmatic thickening fraction(DTF)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
August 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

JinyanXing

Director

The Affiliated Hospital of Qingdao University

Eligibility Criteria

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

Outcomes

Primary Outcomes

diaphragmatic thickening fraction(DTF)

Time Frame: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation

DTF 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 Outcomes

  • Parasternal Intercostal Muscle Ultrasound(baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation)

Study Sites (1)

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