Dual Acupoints Stimulation Alleviates Pulmonary Complication

Overview

Stimulation at acupoints could be of beneficial effects during the perioperative period. In this study the investigators tend to verify the effect of dual acupoints stimulation on pulmonary complications after abdominal surgery in aged patients.

Full Title of Study: “Effect of Dual Acupoints Stimulation on Lung Complication After Abdominal Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 10, 2018

Detailed Description

Postoperative pulmonary complications contributes to the high morbidity of aged patients. The incidence could be as high as 30~50% in those undergoing abdominal surgery. Stimulation at acupoints have been to alleviate inflammatory response,improve pain management and decrease consumption of opioids, indicating a beneficial effect on pulmonary complications. In this study the investigators tend to verify the effect of dual acupoints stimulation on pulmonary complications after abdominal surgery in aged patients.

Interventions

  • Device: acupoint stimulation
    • Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin
  • Device: no treatment
    • electrodes are attached, but no stimulation is given

Arms, Groups and Cohorts

  • Experimental: Acupoint stimulation
    • Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation
  • Sham Comparator: no treatment
    • Electrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given

Clinical Trial Outcome Measures

Primary Measures

  • incidence of pulmonary complications in 30d post-surgery
    • Time Frame: from end of surgery to Day 30 after surgery, totally 30 days
    • incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure

Secondary Measures

  • ICU admission after surgery
    • Time Frame: from end of surgery to Day 30 after surgery, commonly in 24h after surgery
    • incidence of patients admitted to ICU unexpectedly
  • ICU stay after surgery
    • Time Frame: from admission to ICU to being discharged from ICU,averagely 2 days
    • Time of patients stayed in ICU
  • Mortality in 30 days after surgery
    • Time Frame: from end of surgery to Day 30 after surgery, totally 30 days
    • death of all causes
  • incidence of pulmonary complications in 3 days post-surgery
    • Time Frame: from end of surgery to Day 3 after surgery, totally 3 days
    • incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure
  • Hospital stay after surgery
    • Time Frame: from end of surgery to being discharged from hospital,averagely 5 days
    • Time of patients stayed in hospital after surgery
  • expense after surgery
    • Time Frame: from end of surgery to being discharged from hospital,averagely 5 days
    • expense of patients after surgery

Participating in This Clinical Trial

Inclusion Criteria

  • Informed consented – Scheduled for elective abdominal surgery under general anesthesia – Age >=65 yrs Exclusion Criteria:

  • Patients with contraindications to transcutaneous electrical stimulation – Patients with difficulty in communication that may confuse follow-up – emergent surgeries – Patients with pneumonia or needed ventilation before surgery – Patients with history of pulmonary surgery – Scheduled surgery involves thoracic manipulations – Patients who attended clinical studies in the last 3 months

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Air Force Military Medical University, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhihong LU, Clinical Professor – Air Force Military Medical University, China
  • Overall Official(s)
    • Hailong Dong, Prof., Study Chair, Air Force Military Medical University, China
  • Overall Contact(s)
    • Lize Xiong, Prof., 86-29-84775001, mzkxlz@126.com

References

Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. No abstract available.

Guay J, Ochroch EA. Intraoperative use of low volume ventilation to decrease postoperative mortality, mechanical ventilation, lengths of stay and lung injury in patients without acute lung injury. Cochrane Database Syst Rev. 2015 Dec 7;(12):CD011151. doi: 10.1002/14651858.CD011151.pub2.

Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Moine P, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network investigators. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014 Dec;2(12):1007-15. doi: 10.1016/S2213-2600(14)70228-0. Epub 2014 Nov 13. Erratum In: Lancet Respir Med. 2014 Dec;2(12):e23.

Lu Z, Dong H, Wang Q, Xiong L. Perioperative acupuncture modulation: more than anaesthesia. Br J Anaesth. 2015 Aug;115(2):183-93. doi: 10.1093/bja/aev227.

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