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Clinical Trials/NCT05221710
NCT05221710
Unknown
Not Applicable

Evaluation on the Effect of Acupuncture and Neuromuscular Electrical Stimulation on Mechanical Ventilation Patients

The Affiliated Hospital of Qingdao University1 site in 1 country120 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Insufficiency Requiring Mechanical Ventilation
Sponsor
The Affiliated Hospital of Qingdao University
Enrollment
120
Locations
1
Primary Endpoint
ventilator-free days at 28 days
Last Updated
4 years ago

Overview

Brief Summary

Acupuncture is a treatment intervention used globally for a wide variety of disorders. Its efficacy has been established over the course of 3000 years, originating in Asia and diversifying worldwide.The scientific basis for acupuncture remains unclear. Nonetheless, acupuncture releases neurochemical substrates, such as endorphins, serotonin, and norepinephrine.Acupuncture is considered to be a safe treatment when applied by a certified acupuncturist.Acupuncture has already been deployed in the treatment of sepsis or muscle weakness.Studies have revealed that acupuncture significantly improved grip strength and respiratory muscle strength in chronic obstructive pulmonary disease participates.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.The investigators designed a study to compare the effects of acupuncture, electroacupuncture, and neuromuscular electrical stimulation on mechanical ventilation patients with weaning difficulties

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
August 31, 2023
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 mechanical ventilation duration (\>72 h)
  • stable oxygen saturation, fraction of inspired oxygen≤55%, and positive end expiratory pressure (PEEP)≤8 cmH2O
  • dose of dopamine\<10 μg/kg/min and dose of epinephrine\<0.4 μg/kg/min;
  • mean arterial pressure\>75 mmHg and urine output\>1 mL/kg/h
  • good healing of the incision after surgery;
  • normal cognitive function
  • no history of chronic mental illness or chronic obstructive pulmonary disease

Exclusion Criteria

  • Inability to perform physical activities
  • long-term MV prior to admission
  • neurological comorbidities involving muscles
  • irreversible disorders with a 6-month mortality rate of\>50% according to Acute Physiology and Chronic Health Evaluation II (APACHEII)
  • unsound limbs or unstable fractures
  • administration of glucocorticoids (prednisone or other corticosteroid dose equivalents\>20 mg/day) for at least 20 days prior to admission
  • cardiopulmonary resuscitation before admission to the ICU
  • radiotherapy or chemotherapy within the previous 6 months
  • presence of comorbidities, including acute myocarditis, deep venous thrombosis/embolism, and cerebrovascular accident
  • Patients with implanted pacemakers or defibrillators

Outcomes

Primary Outcomes

ventilator-free days at 28 days

Time Frame: up to 28days

Secondary Outcomes

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

Study Sites (1)

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