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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation
• Intervention / Treatment: Behavioral: electroacupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zehua Dong, Dr.; Phone Number: 86-0532-82919386; Email: liuyingwallace@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266555
      • The Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Acupuncture Group; 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; On the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation	Behavioral: electroacupuncture; 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.
No Intervention: Neuromuscular Electrical Stimulation Group; Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Study Director: Jinyan Xing, Dr., The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: January 29, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 29, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Respiratory Failure; weaning difficulty
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: QYFYWZLL26719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No