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Dual Acupoints Stimulation Alleviates Pulmonary Complication (DALAS)

Primary Purpose

Pulmonary Complication, Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupoint stimulation
no treatment
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Complication focused on measuring acupoint stimulation, elderly patients, postoperative pulmonary complications

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Afiliated Hospital of Chongqing Medical University
  • First Afiliated Hospital of Zhengzhou University
  • Xijing Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupoint stimulation

no treatment

Arm Description

Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation

Electrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given

Outcomes

Primary Outcome Measures

incidence of pulmonary complications in 30d post-surgery
incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure

Secondary Outcome Measures

ICU admission after surgery
incidence of patients admitted to ICU unexpectedly
ICU stay after surgery
Time of patients stayed in ICU
Mortality in 30 days after surgery
death of all causes
incidence of pulmonary complications in 3 days post-surgery
incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure
Hospital stay after surgery
Time of patients stayed in hospital after surgery
expense after surgery
expense of patients after surgery

Full Information

First Posted
July 10, 2017
Last Updated
October 27, 2018
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT03230045
Brief Title
Dual Acupoints Stimulation Alleviates Pulmonary Complication
Acronym
DALAS
Official Title
Effect of Dual Acupoints Stimulation on Lung Complication After Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
December 10, 2018 (Anticipated)
Study Completion Date
December 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Complication, Postoperative Complications
Keywords
acupoint stimulation, elderly patients, postoperative pulmonary complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupoint stimulation
Arm Type
Experimental
Arm Description
Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation
Arm Title
no treatment
Arm Type
Sham Comparator
Arm Description
Electrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given
Intervention Type
Device
Intervention Name(s)
acupoint stimulation
Other Intervention Name(s)
transcutaneous electrical acupoint stimulation
Intervention Description
Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin
Intervention Type
Device
Intervention Name(s)
no treatment
Other Intervention Name(s)
control
Intervention Description
electrodes are attached, but no stimulation is given
Primary Outcome Measure Information:
Title
incidence of pulmonary complications in 30d post-surgery
Description
incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure
Time Frame
from end of surgery to Day 30 after surgery, totally 30 days
Secondary Outcome Measure Information:
Title
ICU admission after surgery
Description
incidence of patients admitted to ICU unexpectedly
Time Frame
from end of surgery to Day 30 after surgery, commonly in 24h after surgery
Title
ICU stay after surgery
Description
Time of patients stayed in ICU
Time Frame
from admission to ICU to being discharged from ICU,averagely 2 days
Title
Mortality in 30 days after surgery
Description
death of all causes
Time Frame
from end of surgery to Day 30 after surgery, totally 30 days
Title
incidence of pulmonary complications in 3 days post-surgery
Description
incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure
Time Frame
from end of surgery to Day 3 after surgery, totally 3 days
Title
Hospital stay after surgery
Description
Time of patients stayed in hospital after surgery
Time Frame
from end of surgery to being discharged from hospital,averagely 5 days
Title
expense after surgery
Description
expense of patients after surgery
Time Frame
from end of surgery to being discharged from hospital,averagely 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lize Xiong, Prof.
Phone
86-29-84775001
Email
mzkxlz@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hailong Dong, Prof.
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
First Afiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Min
Phone
86-13508302749
Email
ms89011068@163.com
Facility Name
First Afiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Prof.
Phone
86-13673996966
Email
zhangw571012@126.com
Facility Name
Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lize XIONG, MD
Phone
86-29-84775001
Email
mzkxlz@126.com
First Name & Middle Initial & Last Name & Degree
Zhihong LU, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24548361
Citation
Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. No abstract available.
Results Reference
background
PubMed Identifier
26641378
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.
Results Reference
background
PubMed Identifier
25466352
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. Erratum In: Lancet Respir Med. 2014 Dec;2(12):e23.
Results Reference
background
PubMed Identifier
26170347
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.
Results Reference
background
PubMed Identifier
30514358
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.
Results Reference
derived

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Dual Acupoints Stimulation Alleviates Pulmonary Complication

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