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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03230045
Other study ID # XJH-A-2016-10-10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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