Dual Acupoints Stimulation Alleviates Pulmonary Complication

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Dual Acupoints Stimulation on Lung Complication After Abdominal Surgery

Conditions
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Pulmonary Complication, Postoperative Complications

Intervention / Treatment
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* Device: acupoint stimulation
* Device: no treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupoint stimulation<br>Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation | Device: acupoint stimulation<br>* Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin<br>* Other names: transcutaneous electrical acupoint stimulation;|
| Sham Comparator: no treatment<br>Electrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given | Device: no treatment<br>* electrodes are attached, but no stimulation is given<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| ICU stay after surgery | Time of patients stayed in ICU | from admission to ICU to being discharged from ICU,averagely 2 days | 
| Mortality in 30 days after surgery | 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 | 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 of patients stayed in hospital after surgery | from end of surgery to being discharged from hospital,averagely 5 days | 
| expense after surgery | expense of patients after surgery | from end of surgery to being discharged from hospital,averagely 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupoint stimulation, elderly patients, postoperative pulmonary complications