Dual Acupoints Stimulation Alleviates Pulmonary Complication

Not Applicable

• Conditions: Pulmonary Complication; Postoperative Complications
• Interventions: Device: acupoint stimulation; Device: no treatment

• Registration Number: NCT03230045
• Lead Sponsor: Air Force Military Medical University, China

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.

Study Timeline

• Study Start: 2017-07-10
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-26
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-27
• Last Update Posted: 2018-10-30
• Primary Completion: 2018-12-10
• Study Completion: 2018-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 268

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupoint stimulation	acupoint stimulation	Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation
no treatment	no treatment	Electrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given

Primary Outcome Measures

Name	Time	Method
incidence of pulmonary complications in 30d post-surgery	from end of surgery to Day 30 after surgery, totally 30 days	incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure

Secondary Outcome Measures

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

Trial Locations

Locations (3)

First Afiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

First Afiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China