Dual Acupoints Stimulation Alleviates Pulmonary Complication
DALAS
Effect of Dual Acupoints Stimulation on Lung Complication After Abdominal Surgery
1 other identifier
interventional
268
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2017
CompletedStudy Start
First participant enrolled
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
July 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2018
CompletedOctober 30, 2018
October 1, 2018
1.4 years
July 10, 2017
October 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
ICU admission after surgery
from end of surgery to Day 30 after surgery, commonly in 24h after surgery
ICU stay after surgery
from admission to ICU to being discharged from ICU,averagely 2 days
Mortality in 30 days after surgery
from end of surgery to Day 30 after surgery, totally 30 days
incidence of pulmonary complications in 3 days post-surgery
from end of surgery to Day 3 after surgery, totally 3 days
Hospital stay after surgery
from end of surgery to being discharged from hospital,averagely 5 days
- +1 more secondary outcomes
Study Arms (2)
Acupoint stimulation
EXPERIMENTALAcupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation
no treatment
SHAM COMPARATORElectrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given
Interventions
Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin
electrodes are attached, but no stimulation is given
Eligibility Criteria
You may qualify if:
- Informed consented
- Scheduled for elective abdominal surgery under general anesthesia
- Age \>=65 yrs
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
First Afiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
First Afiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
Related Publications (5)
Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. No abstract available.
PMID: 24548361BACKGROUNDGuay 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.
PMID: 26641378BACKGROUNDSerpa 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.
PMID: 25466352BACKGROUNDLu 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.
PMID: 26170347BACKGROUNDLu 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.
PMID: 30514358DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hailong Dong, Prof.
Air Force Military Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 10, 2017
First Posted
July 26, 2017
Study Start
July 10, 2017
Primary Completion
December 10, 2018
Study Completion
December 10, 2018
Last Updated
October 30, 2018
Record last verified: 2018-10