Dual Acupoints Stimulation Alleviates Pulmonary Complication

Postoperative Complications Clinical Trial

— DALAS  

Official title:

Effect of Dual Acupoints Stimulation on Lung Complication After Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03230045
• Other study ID #: XJH-A-2016-10-10
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: December 10, 2018

Study information

• Verified date: October 2018
• Source: Fourth Military Medical University
• Contact: Lize Xiong, Prof.
• Phone: 86-29-84775001
• Email: mzkxlz[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Pulmonary Complication

Intervention

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

Locations

Country	Name	City	State
China	First Afiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi
China	First Afiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Review. Update in: Cochrane Database Syst Rev. 2018 Jul 09;7:CD011151. — View 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. Review. — View Citation

Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. — View 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. Review. Erratum in: Lancet Respir Med. 2014 Dec;2(12):e23. — View Citation

Outcome

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