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

NCT05221710 | Unknown

• 1 other identifier: QYFYWZLL26719
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Insufficiency Requiring Mechanical Ventilation

Keywords

Respiratory Failure; weaning difficulty

Outcome Measures

Primary Outcomes (1)

• ventilator-free days at 28 days

  up to 28days

Secondary Outcomes (2)

• 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 Arms (3)

Acupuncture Group

NO INTERVENTION

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)

Electroacupuncture Group

EXPERIMENTAL

On the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation

Behavioral: electroacupuncture

Neuromuscular Electrical Stimulation Group

NO INTERVENTION

Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points

Interventions

electroacupuncture BEHAVIORAL

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.

Electroacupuncture Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266555, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Jinyan Xing, Dr.

  The Affiliated Hospital of Qingdao University

  STUDY DIRECTOR

Central Study Contacts

Zehua Dong, Dr.

CONTACT

86-0532-82919386; liuyingwallace@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: February 3, 2022
• Study Start: March 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

CN (1)