<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03230045</url>
  </required_header>
  <id_info>
    <org_study_id>XJH-A-2016-10-10</org_study_id>
    <nct_id>NCT03230045</nct_id>
  </id_info>
  <brief_title>Dual Acupoints Stimulation Alleviates Pulmonary Complication</brief_title>
  <acronym>DALAS</acronym>
  <official_title>Effect of Dual Acupoints Stimulation on Lung Complication After Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stimulation at acupoints could be of beneficial effects during the perioperative period. In&#xD;
      this study the investigators tend to verify the effect of dual acupoints stimulation on&#xD;
      pulmonary complications after abdominal surgery in aged patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pulmonary complications contributes to the high morbidity of aged patients. The&#xD;
      incidence could be as high as 30~50% in those undergoing abdominal surgery. Stimulation at&#xD;
      acupoints have been to alleviate inflammatory response,improve pain management and decrease&#xD;
      consumption of opioids, indicating a beneficial effect on pulmonary complications. In this&#xD;
      study the investigators tend to verify the effect of dual acupoints stimulation on pulmonary&#xD;
      complications after abdominal surgery in aged patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Anticipated">December 10, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of pulmonary complications in 30d post-surgery</measure>
    <time_frame>from end of surgery to Day 30 after surgery, totally 30 days</time_frame>
    <description>incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU admission after surgery</measure>
    <time_frame>from end of surgery to Day 30 after surgery, commonly in 24h after surgery</time_frame>
    <description>incidence of patients admitted to ICU unexpectedly</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay after surgery</measure>
    <time_frame>from admission to ICU to being discharged from ICU,averagely 2 days</time_frame>
    <description>Time of patients stayed in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality in 30 days after surgery</measure>
    <time_frame>from end of surgery to Day 30 after surgery, totally 30 days</time_frame>
    <description>death of all causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of pulmonary complications in 3 days post-surgery</measure>
    <time_frame>from end of surgery to Day 3 after surgery, totally 3 days</time_frame>
    <description>incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay after surgery</measure>
    <time_frame>from end of surgery to being discharged from hospital,averagely 5 days</time_frame>
    <description>Time of patients stayed in hospital after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>expense after surgery</measure>
    <time_frame>from end of surgery to being discharged from hospital,averagely 5 days</time_frame>
    <description>expense of patients after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">268</enrollment>
  <condition>Pulmonary Complication</condition>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Acupoint stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Electrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>acupoint stimulation</intervention_name>
    <description>Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin</description>
    <arm_group_label>Acupoint stimulation</arm_group_label>
    <other_name>transcutaneous electrical acupoint stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>no treatment</intervention_name>
    <description>electrodes are attached, but no stimulation is given</description>
    <arm_group_label>no treatment</arm_group_label>
    <other_name>control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consented&#xD;
&#xD;
          -  Scheduled for elective abdominal surgery under general anesthesia&#xD;
&#xD;
          -  Age &gt;=65 yrs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with contraindications to transcutaneous electrical stimulation&#xD;
&#xD;
          -  Patients with difficulty in communication that may confuse follow-up&#xD;
&#xD;
          -  emergent surgeries&#xD;
&#xD;
          -  Patients with pneumonia or needed ventilation before surgery&#xD;
&#xD;
          -  Patients with history of pulmonary surgery&#xD;
&#xD;
          -  Scheduled surgery involves thoracic manipulations&#xD;
&#xD;
          -  Patients who attended clinical studies in the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hailong Dong, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Air Force Military Medical University, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lize Xiong, Prof.</last_name>
    <phone>86-29-84775001</phone>
    <email>mzkxlz@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Afiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Su Min</last_name>
      <phone>86-13508302749</phone>
      <email>ms89011068@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Afiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wei Zhang, Prof.</last_name>
      <phone>86-13673996966</phone>
      <email>zhangw571012@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital, Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lize XIONG, MD</last_name>
      <phone>86-29-84775001</phone>
      <email>mzkxlz@126.com</email>
    </contact>
    <investigator>
      <last_name>Zhihong LU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. No abstract available.</citation>
    <PMID>24548361</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26641378</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25466352</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26170347</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>October 27, 2018</last_update_submitted>
  <last_update_submitted_qc>October 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Zhihong LU</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>acupoint stimulation</keyword>
  <keyword>elderly patients</keyword>
  <keyword>postoperative pulmonary complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03230045
org study id: XJH-A-2016-10-10
nct id: NCT03230045
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: incidence of pulmonary complications in 30d post-surgery
time frame: from end of surgery to Day 30 after surgery, totally 30 days
description: incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure
measure: ICU admission after surgery
time frame: from end of surgery to Day 30 after surgery, commonly in 24h after surgery
description: incidence of patients admitted to ICU unexpectedly
measure: ICU stay after surgery
time frame: from admission to ICU to being discharged from ICU,averagely 2 days
description: Time of patients stayed in ICU
measure: Mortality in 30 days after surgery
time frame: from end of surgery to Day 30 after surgery, totally 30 days
description: death of all causes
measure: incidence of pulmonary complications in 3 days post-surgery
time frame: from end of surgery to Day 3 after surgery, totally 3 days
description: incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure
measure: Hospital stay after surgery
time frame: from end of surgery to being discharged from hospital,averagely 5 days
description: Time of patients stayed in hospital after surgery
measure: expense after surgery
time frame: from end of surgery to being discharged from hospital,averagely 5 days
description: expense of patients after surgery
arm group label: Acupoint stimulation
arm group type: Experimental
description: Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation
arm group label: no treatment
arm group type: Sham Comparator
description: Electrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given
intervention type: Device
intervention name: acupoint stimulation
description: Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin
arm group label: Acupoint stimulation
other name: transcutaneous electrical acupoint stimulation
intervention type: Device
intervention name: no treatment
description: electrodes are attached, but no stimulation is given
arm group label: no treatment
other name: control
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Hailong Dong, Prof.
role: Study Chair
affiliation: Air Force Military Medical University, China
last name: Lize Xiong, Prof.
phone: 86-29-84775001
email: mzkxlz@126.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. No abstract available.
PMID: 24548361
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.
PMID: 26641378
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.
PMID: 25466352
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.
PMID: 26170347
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Zhihong LU
investigator title: Clinical Professor
mesh term: Postoperative Complications
sharing ipd: Undecided