Systemic Inflammatory Response SyndromeNCT02193477
Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery
A study testing TEAS in people with Systemic Inflammatory Response Syndrome and Inflammation, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in patients undergoing radical surgery for gastric cancer Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Inflammation
- What is being tested?
- TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jan 2015
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>30yrs,<75yrs
- ASA 1-2
- Scheduled for radical surgery for gastric cancer under general anesthesia；
- Informed consented
Who cannot join
- Patients with implanted pacemakers
- Patients with severe hypertension or cardiac dysfunction；
- Patients with severe pulmonary disease
- Patients with hemoglobin<90g/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS)on the Incidence Rate of Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Radical Surgery for Gastric Cancer
The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in patients undergoing radical surgery for gastric cancer
Read the detailed description
Patients undergoing elective radical surgery for gastric cancer under general anesthesia were randomly assigned to three groups, control group , TEAS group and sham TEAS group.
TEAS group receiving TEAS before general anesthesia induction , 1th day and 2nd day after surgery. TEAS was given through electrodes attached to specific acupoints. The time for TEAS was 30min.
Sham TEAS group receiving sham TEAS before general anesthesia induction , 1th day and 2nd day after surgery. Sham TEAS was given through electrodes attached to non-acupoints. The time for sham TEAS was also 30min.
Control group were given no TEAS. Incidence rates of SIRS in each group were compared .Venous blood samples from all groups(control group , TEAS group and sham TEAS group) were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,Tumor Necrosis Factor- alpha(TNF-α),Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.
- Being tested
- TEAS, Sham TEAS
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASDevice
Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
Sham TEASDevice
Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients were given no TEAS. |
| TEAS Treatment | Experimental | Patients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery. Receives: Device: TEAS |
| Sham TEAS | Sham comparator | Patients were given 30min of sham TEAS before general anesthesia induction,1th day and 2nd day after surgery. Receives: Device: Sham TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of SIRS
SIRS is defined as 2 or more of the following variables :
- Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F)
- Heart rate of more than 90 beats per minute
- Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg
- Abnormal white blood cell count (>12,000/µL or < 4,000/µL or >10% immature granulocyte forms)
Incidence rate of SIRS is calculated using the following formula:
(Number of SIRS Cases within the group) / (Number of Cases within the group)
Measured: 1st day after surgery
Secondary outcomes (2)
Change of Inflammatory cytokines
Venous blood samples were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,TNF-α,Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.
Measured: 30 minutes before general anesthesia induction and 1st and 3rd day after the surgery
Incidence rate of SIRS
SIRS is defined as 2 or more of the following variables :
Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F) Heart rate of more than 90 beats per minute Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg Abnormal white blood cell count (>12,000/µL or < 4,000/µL or >10% immature granulocyte forms)
Incidence rate of SIRS is calculated using the following formula:
(Number of SIRS Cases within the group) / (Number of Cases within the group)
Measured: 3rd day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, QiangWang,MD, Air Force Military Medical University, China
- Investigators
- Qiang Wang, MD, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193477
- Sponsor's protocol ID
- Gjian
- Status last verified
- Mar 2015
- First submitted
- 6 Jul 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS)on the Incidence Rate of Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Radical Surgery for Gastric Cancer
- ClinicalTrials.gov ID
- NCT02193477
- Acronym / sponsor ID
- Gjian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Jul 2014 (estimated)
- 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.
The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in patients undergoing radical surgery for gastric cancer
Detailed description
Patients undergoing elective radical surgery for gastric cancer under general anesthesia were randomly assigned to three groups, control group , TEAS group and sham TEAS group.
TEAS group receiving TEAS before general anesthesia induction , 1th day and 2nd day after surgery. TEAS was given through electrodes attached to specific acupoints. The time for TEAS was 30min.
Sham TEAS group receiving sham TEAS before general anesthesia induction , 1th day and 2nd day after surgery. Sham TEAS was given through electrodes attached to non-acupoints. The time for sham TEAS was also 30min.
Control group were given no TEAS. Incidence rates of SIRS in each group were compared .Venous blood samples from all groups(control group , TEAS group and sham TEAS group) were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,Tumor Necrosis Factor- alpha(TNF-α),Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients were given no TEAS. |
| TEAS Treatment | Experimental | Device: TEASPatients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery. |
| Sham TEAS | Sham comparator | Device: Sham TEASPatients were given 30min of sham TEAS before general anesthesia induction,1th day and 2nd day after surgery. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>30yrs,<75yrs
- ASA 1-2
- Scheduled for radical surgery for gastric cancer under general anesthesia；
- Informed consented
Key exclusion criteria (4 listed)
- Patients with implanted pacemakers
- Patients with severe hypertension or cardiac dysfunction；
- Patients with severe pulmonary disease
- Patients with hemoglobin<90g/L
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 |
|---|---|---|
| TEASElectric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery. | Device | TEAS Treatment |
| Sham TEASElectric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery. | Device | Sham TEAS |
Primary outcome
Incidence rate of SIRS
Time frame: 1st day after surgery
SIRS is defined as 2 or more of the following variables : 1. Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F) 2. Heart rate of more than 90 beats per minute 3. Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg 4. Abnormal white blood cell count (>12,000/µL or < 4,000/µL or >10% immature granulocyte forms) Incidence rate of SIRS is calculated using the following formula: (Number of SIRS Cases within the group) / (Number of Cases within the group)
2 secondary outcomes
Change of Inflammatory cytokines
Time frame: 30 minutes before general anesthesia induction and 1st and 3rd day after the surgery
Incidence rate of SIRS
Time frame: 3rd day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
Qiang Wang, MD study chair
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS in people with Systemic Inflammatory Response Syndrome and Inflammation, run by Air Force Military Medical University, China at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of SIRS (time frame: 1st day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2015.