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

Study Overview
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Brief Summary
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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

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

Conditions
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Respiratory Insufficiency Requiring Mechanical Ventilation

Intervention / Treatment
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* Behavioral: electroacupuncture


Participation Criteria
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Eligibility Criteria
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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 Pregnancy and lactation patients Patients with active bleeding or bleeding tendency Skin infection or injury at the acupuncture site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Acupuncture Group<br>The acupuncture treatment will be performed by the technique of lifting, thrusting, twirling and rotating the needle until the patient is being De-qi (getting a numbness or other acupuncture feeling) | |
| Experimental: Electroacupuncture Group<br>On the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation | Behavioral: electroacupuncture<br>* The acupuncture treatment will be performed by the technique of lifting, thrusting, twirling and rotating the needle until the patient is being De-qi (getting a numbness or other acupuncture feeling).The needle will be kept in place for approximately 30 minutes. The point of acupuncture is determined by a traditional Chinese medicine doctor. Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points. On the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation in electroacupuncture group.<br>|
| No Intervention: Neuromuscular Electrical Stimulation Group<br>Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator-free days at 28 days |  | up to 28days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic thickening fraction(DTF) | 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%. The values for 3 consecutive respiratory cycles were recorded and the average value was taken as the final value | baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation | 
| Parasternal Intercostal Muscle Ultrasound | A 10-15 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. | baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Failure, weaning difficulty