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Status unknownNCT05221710Updated Feb 3, 2022

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

An interventional study of electroacupuncture in Respiratory Insufficiency Requiring Mechanical Ventilation, sponsored by The Affiliated Hospital of Qingdao University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by The Affiliated Hospital of Qingdao University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

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Conditions studied

  • Respiratory Insufficiency Requiring Mechanical Ventilation

Keywords

  • Respiratory Failure
  • weaning difficulty
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 120 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • No intervention
    Neuromuscular Electrical Stimulation Group

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

Interventions

  • Behavioralelectroacupuncture

    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.

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What researchers measure

Primary outcomes

  1. ventilator-free days at 28 days

    Time frame: up to 28days

Secondary outcomes

  1. 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

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

  2. 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.

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

07

Study locations

1 site
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266555, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05221710
Lead sponsor
The Affiliated Hospital of Qingdao University
Responsible party
JinyanXing (Director, The Affiliated Hospital of Qingdao University) — Principal investigator
First posted
Feb 3, 2022
Start date
Mar 1, 2022 (estimated)
Primary completion
Aug 31, 2023 (estimated)
Completion
Aug 31, 2023 (estimated)
Last update
Feb 3, 2022

Study contacts

Zehua Dong, Dr.
Contact
liuyingwallace@163.com
86-0532-82919386
Jinyan Xing, Dr.
study director · The Affiliated Hospital of Qingdao University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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