Electroacupuncture to Assist Ventilator Weaning in Severe Stroke

NCT04816201 | Recruiting

• 1 other identifier: ZF2021-035
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Severe Stroke; Electroacupuncture

Keywords

ventilator weaning; severe stroke; electroacupuncture

Outcome Measures

Primary Outcomes (1)

• ventilation duration

  hours

  within 21 days after enrollment

Secondary Outcomes (5)

• rate of successful ventilator weaning

  within 21 days after enrollment

• diaphragm muscle thickness

  on day 7, day 14 and day 21

• diaphragm thickening fraction

  on day 7, day 14 and day 21

• diaphragm excursion

  on day 7, day 14 and day 21

• rate of death

  within 21 days after enrollment

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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

Sham electroacupuncture

SHAM COMPARATOR

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

Interventions

Electroacupuncture OTHER

Electroacupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36).

Electroacupuncture; Sham electroacupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years and ≤ 75 years ;
• 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;
• GCS on admission ≤ 12 or NIHSS on admission ≥ 11 or APACHEⅡ ≥ 15;
• received mechanical ventilation;
• written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.

You may not qualify if:

• expected to be ventilated for \< 24 h;
• already ventilated for \> 72 h;
• GCS \<5;
• with unstable vital signs and requiring the use of vasoactive agents;
• concomitant medical illness that would interfere with the outcome assessments and/or follow-up;
• 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;
• had acute skin injury on the selected acupoints;
• currently participating in other investigational trials.

Sponsors & Collaborators

• The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 23720268 BACKGROUND

• 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.

  PMID: 28698263 BACKGROUND

• 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.

  PMID: 28867413 BACKGROUND

• 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.

  PMID: 32426748 BACKGROUND

• 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.

  PMID: 31107378 BACKGROUND

• 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.

  PMID: 30904733 BACKGROUND

• 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.

  PMID: 30389829 BACKGROUND

• 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.

  PMID: 31340846 BACKGROUND

• 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.

  PMID: 26047468 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular 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

• Lixin Wang, PhD

  The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Fang Yuan, PhD

CONTACT

+86-20-81887233; yuanfang@gzucm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)