Clinical trial NCT03230045: Dual Acupoints Stimulation Alleviates Pulmonary Complication
Official title: Effect of Dual Acupoints Stimulation on Lung Complication After Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Complication
Postoperative Complications
Keywords: acupoint stimulation
elderly patients
postoperative pulmonary complications
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 268
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of pulmonary complications in 30d post-surgery
timeFrame: from end of surgery to Day 30 after surgery, totally 30 days
Secondary outcomes:
measure: ICU admission after surgery
timeFrame: from end of surgery to Day 30 after surgery, commonly in 24h after surgery
measure: ICU stay after surgery
timeFrame: from admission to ICU to being discharged from ICU,averagely 2 days
measure: Mortality in 30 days after surgery
timeFrame: from end of surgery to Day 30 after surgery, totally 30 days
measure: incidence of pulmonary complications in 3 days post-surgery
timeFrame: from end of surgery to Day 3 after surgery, totally 3 days
measure: Hospital stay after surgery
timeFrame: from end of surgery to being discharged from hospital,averagely 5 days
measure: expense after surgery
timeFrame: from end of surgery to being discharged from hospital,averagely 5 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: First Afiliated Hospital of Chongqing Medical University
state: Chongqing
city: Zhengzhou
country: China
facility: First Afiliated Hospital of Zhengzhou University
state: Henan
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Hailong Dong, Prof.
role: STUDY_CHAIR
References:
citation: Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: Lu ZH, Dong HL, Huang-Fu JW, Fan XJ, Zhao WX, Min S, Zhang W, Liu MF, Wang YH, Wang LN, Xiong LZ. Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial. Trials. 2018 Dec 4;19(1):669. doi: 10.1186/s13063-018-3052-2.