Dual Acupoints Stimulation Alleviates Pulmonary Complication (DALAS)

October 27, 2018 updated by: Zhihong LU, Air Force Military Medical University, China

Effect of Dual Acupoints Stimulation on Lung Complication After Abdominal Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • Not yet recruiting
        • First Afiliated Hospital of Chongqing Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Not yet recruiting
        • First Afiliated Hospital of Zhengzhou University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital, Fourth Military Medical University
        • Contact:
        • Principal Investigator:
          • Zhihong LU, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupoint stimulation
Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation
Device: acupoint stimulation
Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin
Other Names:
  • transcutaneous electrical acupoint stimulation
Sham Comparator: no treatment
Electrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given
Device: no treatment
electrodes are attached, but no stimulation is given
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of pulmonary complications in 30d post-surgery
Time Frame: from end of surgery to Day 30 after surgery, totally 30 days
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Study Chair: Hailong Dong, Prof., Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Anticipated)

December 10, 2018

Study Completion (Anticipated)

December 10, 2018

Study Registration Dates

First Submitted

July 10, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 27, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-2016-10-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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