Electroacupuncture to Assist Ventilator Weaning in Severe Stroke

Electroacupuncture to Assist Ventilator Weaning in Severe Stroke: a Randomized, Sham-controlled Pilot Study

The purpose of this study is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke

Study Overview

• Status: Recruiting
• Conditions: Electroacupuncture; Severe Stroke
• Intervention / Treatment: Other: Electroacupuncture

Detailed Description

Disuse atrophy of the major respiratory muscles and diaphragmatic dysfunction often develop during mechanical ventilation, and cause difficulties in ventilator weaning. Electroacupuncture was indicated to promote activities of diaphragm and improve diaphragmatic function. Our aim is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke. 100 eligible patients will be randomly assigned to receive electroacupuncture or sham electroacupuncture treatment one session per day until the success of ventilator weaning (up to 21 days). The primay outcome is the ventilation duration within 21 days after enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Yuan, PhD; Phone Number: +86-20-81887233; Email: yuanfang@gzucm.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Contact: Fang Yuan, PhD; Phone Number: +86-20-81887233; Email: plawlx@gzucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. age ≥ 18 years and ≤ 75 years ;
2. within 7 days after the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain;
3. GCS on admission ≤ 12 or NIHSS on admission ≥ 11 or APACHEⅡ ≥ 15;
4. received mechanical ventilation;
5. written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.

Exclusion Criteria:

1. expected to be ventilated for < 24 h;
2. already ventilated for > 72 h;
3. GCS <5;
4. with unstable vital signs and requiring the use of vasoactive agents;
5. concomitant medical illness that would interfere with the outcome assessments and/or follow-up;
6. had spinal cord injury above T8 level, or lower motor neuron impairment, or neuromuscular junction impairment，or chest wall deformities, or chest wall injuries within 6 months, or chest or abdominal surgery within 4 week, or were pregnant;
7. had acute skin injury on the selected acupoints;
8. currently participating in other investigational trials.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture; Participants in the electroacupuncture group received acupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36). After skin disinfection, sterile adhesive pads were placed on these acupoints, and acupuncture needles were inserted through the adhesive pads approximately 50 to 60 mm into the skin. Paired electrodes from the electroacupuncture apparatus were attached to the needle handles of Xuanji (CV21) and Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), bilateral Liangmen (ST21), and bilateral Zusanli (ST36). The electroacupuncture stimulation lasted for 30 minutes with an intermittent wave of 50 Hz and a current intensity of 1 to 5mA (preferably with the skin around the acupoints shivering mildly without pain). Participants received 1 treatment session per day until the success of ventilator weaning (up to 21 days).	Other: Electroacupuncture; Electroacupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36).
Sham Comparator: Sham electroacupuncture; Participants in the sham electroacupuncture group received sham electroacupuncture with a pragmatic placebo needle on sham acupoints. The sham Xuanji (CV21) point was 1 cun (≈20 mm) above to Xuanji (CV21), the sham Danzhong (CV27) point was 1 cun(≈20mm) above to Danzhong (CV27), the sham Qihai (CV06) point was 1 cun(≈20mm) above to Qihai (CV06), the sham Guanyuan (CV04) point was 1 cun(≈20mm) above to Guanyuan (CV04), the sham Liangmen (ST21) point was 1 cun(≈20mm) lateral to Liangmen (ST21), and the sham Zusanli (ST36) point was 1 cun(≈20mm) lateral to Zusanli (ST36). Procedures, electrode placements, and other treatment settings were the same as in the electroacupuncture group but with no skin penetration or electricity output.	Other: Electroacupuncture; Electroacupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilation duration	hours	within 21 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of successful ventilator weaning	percentage	within 21 days after enrollment
diaphragm muscle thickness	mm	on day 7, day 14 and day 21
diaphragm thickening fraction	percentage	on day 7, day 14 and day 21
diaphragm excursion	mm	on day 7, day 14 and day 21
rate of death	percentage	within 21 days after enrollment

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Investigators: Study Director: Lixin Wang, PhD, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Publications and helpful links

General Publications

• Kim WY, Lim CM. Ventilator-Induced Diaphragmatic Dysfunction: Diagnosis and Role of Pharmacological Agents. Respir Care. 2017 Nov;62(11):1485-1491. doi: 10.4187/respcare.05622. Epub 2017 Jul 11.
• Tobin MJ, Laghi F, Jubran A. Ventilatory failure, ventilator support, and ventilator weaning. Compr Physiol. 2012 Oct;2(4):2871-921. doi: 10.1002/cphy.c110030.
• Chen YJ, Hwang SL, Li CR, Yang CC, Huang KL, Lin CY, Lee CY. Vagal withdrawal and psychological distress during ventilator weaning and the related outcomes. J Psychosom Res. 2017 Oct;101:10-16. doi: 10.1016/j.jpsychores.2017.07.012. Epub 2017 Jul 29.
• Ataya A, Silverman EP, Bagchi A, Sarwal A, Criner GJ, McDonagh DL. Temporary Transvenous Diaphragmatic Neurostimulation in Prolonged Mechanically Ventilated Patients: A Feasibility Trial (RESCUE 1). Crit Care Explor. 2020 Apr 29;2(4):e0106. doi: 10.1097/CCE.0000000000000106. eCollection 2020 Apr.
• Essouri S, Baudin F, Mortamet G, Beck J, Jouvet P, Emeriaud G. Relationship Between Diaphragmatic Electrical Activity and Esophageal Pressure Monitoring in Children. Pediatr Crit Care Med. 2019 Jul;20(7):e319-e325. doi: 10.1097/PCC.0000000000001981.
• Abdelwahed WM, Abd Elghafar MS, Amr YM, Alsherif SEI, Eltomey MA. Prospective study: Diaphragmatic thickness as a predictor index for weaning from mechanical ventilation. J Crit Care. 2019 Aug;52:10-15. doi: 10.1016/j.jcrc.2019.03.006. Epub 2019 Mar 15. No abstract available.
• Bellani G, Bronco A, Arrigoni Marocco S, Pozzi M, Sala V, Eronia N, Villa G, Foti G, Tagliabue G, Eger M, Pesenti A. Measurement of Diaphragmatic Electrical Activity by Surface Electromyography in Intubated Subjects and Its Relationship With Inspiratory Effort. Respir Care. 2018 Nov;63(11):1341-1349. doi: 10.4187/respcare.06176.
• McCaughey EJ, Jonkman AH, Boswell-Ruys CL, McBain RA, Bye EA, Hudson AL, Collins DW, Heunks LMA, McLachlan AJ, Gandevia SC, Butler JE. Abdominal functional electrical stimulation to assist ventilator weaning in critical illness: a double-blinded, randomised, sham-controlled pilot study. Crit Care. 2019 Jul 24;23(1):261. doi: 10.1186/s13054-019-2544-0.
• McCaughey EJ, Berry HR, McLean AN, Allan DB, Gollee H. Abdominal Functional Electrical Stimulation to Assist Ventilator Weaning in Acute Tetraplegia: A Cohort Study. PLoS One. 2015 Jun 5;10(6):e0128589. doi: 10.1371/journal.pone.0128589. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: electroacupuncture; ventilator weaning; severe stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ZF2021-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The detailed datasets used and/or analyzed during the current study are available upon reasonable request.

Drug and device information, study documents

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