Pulmonary ComplicationDALASNCT03230045
Dual Acupoints Stimulation Alleviates Pulmonary Complication
A study testing acupoint stimulation and no treatment in people with Pulmonary Complication and Postoperative Complications, run by Air Force Military Medical University, China at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pulmonary Complication, Postoperative Complications
- What is being tested?
- acupoint stimulation and no treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 3 sitesChina
- Study dates
- 10 Jul 2017to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Informed consented
- Scheduled for elective abdominal surgery under general anesthesia
- Age >=65 yrs
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
First Afiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Su Min, 86-13508302749, ms89011068@163.com
- Recruiting
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Lize XIONG, MD, 86-29-84775001, mzkxlz@126.com
Zhihong LU, MD
- Not yet recruiting
First Afiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Wei Zhang, Prof., 86-13673996966, zhangw571012@126.com
About this study
Official title: 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.
Read the 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.
- Being tested
- acupoint stimulation, no treatment
- Keywords
- acupoint stimulation, elderly patients, postoperative pulmonary complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint stimulationDevice
Also called transcutaneous electrical acupoint stimulation
Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin
no treatmentDevice
Also called control
electrodes are attached, but no stimulation is given
| Study group | Role | What they receive |
|---|---|---|
| Acupoint stimulation | Experimental | Acupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation Receives: Device: acupoint stimulation |
| no treatment | Sham comparator | Electrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given Receives: Device: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pulmonary complications in 30d post-surgery
incidence of pulmonary complications including pneumonia,atelectasis, pleural effusion and respiratory failure
Measured: from end of surgery to Day 30 after surgery, totally 30 days
Secondary outcomes (6)
ICU admission after surgery
incidence of patients admitted to ICU unexpectedly
Measured: from end of surgery to Day 30 after surgery, commonly in 24h after surgery
ICU stay after surgery
Time of patients stayed in ICU
Measured: from admission to ICU to being discharged from ICU,averagely 2 days
Mortality in 30 days after surgery
death of all causes
Measured: 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
Measured: from end of surgery to Day 3 after surgery, totally 3 days
Hospital stay after surgery
Time of patients stayed in hospital after surgery
Measured: from end of surgery to being discharged from hospital,averagely 5 days
expense after surgery
expense of patients after surgery
Measured: from end of surgery to being discharged from hospital,averagely 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start10 Jul 2017
- Primary completion10 Dec 2018 (estimated)
- Study completion10 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Hailong Dong, Prof., Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230045
- Sponsor's protocol ID
- XJH-A-2016-10-10
- Acronym
- DALAS
- Status last verified
- Oct 2018
- First submitted
- 10 Jul 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. No abstract available.
PubMed 24548361Guay 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.
PubMed 26641378Serpa 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.
PubMed 25466352Lu 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.
PubMed 26170347Lu 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.
PubMed 30514358
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dual Acupoints Stimulation on Lung Complication After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03230045
- Acronym / sponsor ID
- DALAS / XJH-A-2016-10-10
- Keywords
- acupoint stimulation, elderly patients, postoperative pulmonary complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 10 Dec 2018 (estimated)
- Study completion
- 10 Dec 2018 (estimated)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupoint stimulation | Experimental | Device: acupoint stimulationAcupoint Zhongfu and Zusanli are stimulated by transcutaneous electrical stimulation |
| no treatment | Sham comparator | Device: no treatmentElectrodes are attached to Acupoint Zhongfu and Zusanli, but no stimulation is given |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Informed consented
- Scheduled for elective abdominal surgery under general anesthesia
- Age >=65 yrs
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupoint stimulationAlso: transcutaneous electrical acupoint stimulationAcupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin | Device | Acupoint stimulation |
| no treatmentAlso: controlelectrodes are attached, but no stimulation is given | Device | no treatment |
Primary outcome
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
6 secondary outcomes
ICU admission after surgery
Time frame: 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
Mortality in 30 days after surgery
Time frame: 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
Hospital stay after surgery
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Background: PubMed 24548361Rajamanickam T. Peri-operative care for the elderly. Anaesthesia. 2014 Mar;69(3):284-5. doi: 10.1111/anae.12616. No abstract available.
- Background: PubMed 26641378Guay 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.
- Background: PubMed 25466352Serpa 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.
- Background: PubMed 26170347Lu 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.
- Derived from this study: PubMed 30514358Lu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hailong Dong, Prof. study chair
Air Force Military Medical University, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupoint stimulation and no treatment in people with Pulmonary Complication and Postoperative Complications, run by Air Force Military Medical University, China at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lize Xiong, Prof. (86-29-84775001, mzkxlz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of pulmonary complications in 30d post-surgery (time frame: from end of surgery to Day 30 after surgery, totally 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03230045, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.