Dual Acupoints Stimulation Alleviates Pulmonary Complication

NCT ID: NCT03230045

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2018-12-10

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.

Conditions

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Pulmonary Complication Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Acupoint stimulation

Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation

Group Type EXPERIMENTAL

acupoint stimulation

Intervention Type DEVICE

Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin

no treatment

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

Group Type SHAM_COMPARATOR

no treatment

Intervention Type DEVICE

electrodes are attached, but no stimulation is given

Interventions

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acupoint stimulation

Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin

Intervention Type DEVICE

no treatment

electrodes are attached, but no stimulation is given

Intervention Type DEVICE

Other Intervention Names

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transcutaneous electrical acupoint stimulation control

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hailong Dong, Prof.

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

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First Afiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

First Afiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lize Xiong, Prof.

Role: CONTACT

86-29-84775001

Facility Contacts

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Su Min

Role: primary

86-13508302749

Wei Zhang, Prof.

Role: primary

86-13673996966

Lize XIONG, MD

Role: primary

86-29-84775001

References

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Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. No abstract available.

Reference Type BACKGROUND
PMID: 24548361 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26641378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25466352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26170347 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30514358 (View on PubMed)

Other Identifiers

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XJH-A-2016-10-10

Identifier Type: -

Identifier Source: org_study_id

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