Delirium, PostoperativeNCT06318351
Transcutaneous Acupoint Electrical Stimulation and Postoperative Delirium Delirium
An observational study of Delirium, Postoperative, run by Qin Zhang at 2 sites in China.
Trial summary
Investigating postoperative delirium in patients undergoing thoracoscopic lung resection surgery who have received or not received relevant transcutaneous acupoint electrical stimulation treatment preoperatively, observing postoperative recovery quality indicators, evaluating the necessity of treatment, and clarifying… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Postoperative
- What is being tested?
- transcutaneous acupoint electrical stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 476 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2024to 30 Aug 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing thoracoscopic pneumonectomy
Who may be able to join
- Voluntary participation in the study;
- Age ≥ 18 years;
- Patients scheduled for thoracoscopic lung resection surgery;
- ASA grade I-III.
Who cannot join
- History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23;
- History of opioid addiction, long-term use of analgesic drugs, or psychotropic drugs;
- Severe cardiovascular and cerebrovascular diseases;
- Severe liver and kidney dysfunction: Child-Pugh grade B, C patients, patients requiring regular dialysis, etc.;
- Pregnant or postpartum women;
- Patients with language communication barriers;
- Deemed unsuitable for participation by the researchers.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510000
Jiemin Deng, 2780, qin4298@sina.com
Jiemin Deng
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qin Zhang, phd, 15717154768, qzhang8@tjh.tjmu.edu.cn
Qin Zhang, phd
About this study
Official title: Observing the Influence of Transcutaneous Acupoint Electrical Stimulation on Postoperative Delirium After Thoracoscopic Lung Resection Surgery - a Multicenter Cohort Study
Investigating postoperative delirium in patients undergoing thoracoscopic lung resection surgery who have received or not received relevant transcutaneous acupoint electrical stimulation treatment preoperatively, observing postoperative recovery quality indicators, evaluating the necessity of treatment, and clarifying the potential mechanisms by which transcutaneous acupoint electrical stimulation may improve postoperative delirium.
Read the detailed description
Research design type: multicenter, prospective, cohort observational trial. The leading unit is Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, and the participating unit is Guangdong Provincial Hospital of Chinese Medicine (a large comprehensive traditional Chinese medicine hospital directly under the National Administration of Traditional Chinese Medicine), skilled in using traditional Chinese medicine treatment methods to improve postoperative recovery quality. Participating in a multicenter clinical study on transcutaneous acupoint electrical stimulation to improve postoperative delirium after thoracoscopic surgery will help collectively explore the perioperative application and mechanism of action of traditional Chinese medicine techniques for acupoint stimulation.
Firstly, patients meeting the inclusion criteria from the Department of Thoracic Surgery of Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology and Guangdong Provincial Hospital of Chinese Medicine will be recruited. Upon admission, the Mini-Mental State Examination (MMSE) will be used as a routine clinical assessment to screen all patients for cognitive status to reduce the impact of cognitive impairments on subsequent observations. Subsequently, based on whether patients receive transcutaneous acupoint electrical stimulation treatment by an anesthesiologist, patients will be divided into two groups (yes or no for receiving the treatment). Their recovery period, delirium assessment within 7 days postoperatively, as well as assessments of sleep, pain, etc., will be observed. Preoperative and postoperative peripheral blood samples will be collected for testing related indicators. Information on demographic characteristics, discharge diagnosis, laboratory indicators at admission and discharge, postoperative complications, length of hospital stay, disease awareness, etc., will be collected from the medical records system for statistical analysis to explore the correlation between transcutaneous acupoint electrical stimulation and postoperative delirium in patients undergoing thoracoscopic lung resection.
- Conditions
- Delirium, Postoperative
- Being tested
- transcutaneous acupoint electrical stimulation
- Keywords
- Delirium, Thoracoscopic lung resection surgery
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous acupoint electrical stimulationProcedure or surgery
This is a safe and non-invasive procedure, similar to an electrode sheet, which applies a weak current to a specific site to achieve the purpose of acupoint stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electrical Acupoint Stimulation | The effect of Transcutaneous Electrical Acupoint Stimulation on postoperative vision was observed according to anesthesiologist's habit of using or not using it. Receives: Procedure: transcutaneous acupoint electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Mini-Mental State Examination, MMSE
Measured: 7days
Secondary outcomes (1)
Recovery
Questionnaire
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Feb 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, PostoperativeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 476 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Qin Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Qin Zhang, Tongji Hospital
- Investigators
- Qin Zhang, phd, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318351
- Sponsor's protocol ID
- TJ-IRB202402015
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing the Influence of Transcutaneous Acupoint Electrical Stimulation on Postoperative Delirium After Thoracoscopic Lung Resection Surgery - a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06318351
- Acronym / sponsor ID
- TJ-IRB202402015
- Conditions
- Delirium, Postoperative
- Keywords
- Delirium, Thoracoscopic lung resection surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Qin ZhangUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 19 Mar 2024 (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.
Investigating postoperative delirium in patients undergoing thoracoscopic lung resection surgery who have received or not received relevant transcutaneous acupoint electrical stimulation treatment preoperatively, observing postoperative recovery quality indicators, evaluating the necessity of treatment, and clarifying the potential mechanisms by which transcutaneous acupoint electrical stimulation may improve postoperative delirium.
Detailed description
Research design type: multicenter, prospective, cohort observational trial. The leading unit is Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, and the participating unit is Guangdong Provincial Hospital of Chinese Medicine (a large comprehensive traditional Chinese medicine hospital directly under the National Administration of Traditional Chinese Medicine), skilled in using traditional Chinese medicine treatment methods to improve postoperative recovery quality. Participating in a multicenter clinical study on transcutaneous acupoint electrical stimulation to improve postoperative delirium after thoracoscopic surgery will help collectively explore the perioperative application and mechanism of action of traditional Chinese medicine techniques for acupoint stimulation.
Firstly, patients meeting the inclusion criteria from the Department of Thoracic Surgery of Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology and Guangdong Provincial Hospital of Chinese Medicine will be recruited. Upon admission, the Mini-Mental State Examination (MMSE) will be used as a routine clinical assessment to screen all patients for cognitive status to reduce the impact of cognitive impairments on subsequent observations. Subsequently, based on whether patients receive transcutaneous acupoint electrical stimulation treatment by an anesthesiologist, patients will be divided into two groups (yes or no for receiving the treatment). Their recovery period, delirium assessment within 7 days postoperatively, as well as assessments of sleep, pain, etc., will be observed. Preoperative and postoperative peripheral blood samples will be collected for testing related indicators. Information on demographic characteristics, discharge diagnosis, laboratory indicators at admission and discharge, postoperative complications, length of hospital stay, disease awareness, etc., will be collected from the medical records system for statistical analysis to explore the correlation between transcutaneous acupoint electrical stimulation and postoperative delirium in patients undergoing thoracoscopic lung resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Acupoint Stimulation | – | Procedure: transcutaneous acupoint electrical stimulationThe effect of Transcutaneous Electrical Acupoint Stimulation on postoperative vision was observed according to anesthesiologist's habit of using or not using it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing thoracoscopic pneumonectomy
Key inclusion criteria (4 listed)
- Voluntary participation in the study;
- Age ≥ 18 years;
- Patients scheduled for thoracoscopic lung resection surgery;
- ASA grade I-III.
Key exclusion criteria (7 listed)
- History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23;
- History of opioid addiction, long-term use of analgesic drugs, or psychotropic drugs;
- Severe cardiovascular and cerebrovascular diseases;
- Severe liver and kidney dysfunction: Child-Pugh grade B, C patients, patients requiring regular dialysis, etc.;
- Pregnant or postpartum women;
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 |
|---|---|---|
| transcutaneous acupoint electrical stimulationThis is a safe and non-invasive procedure, similar to an electrode sheet, which applies a weak current to a specific site to achieve the purpose of acupoint stimulation. | Procedure or surgery | Transcutaneous Electrical Acupoint Stimulation |
Primary outcome
Delirium
Time frame: 7days
Mini-Mental State Examination, MMSE
1 secondary outcome
Recovery
Time frame: 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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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.
Qin Zhang, phd principal investigator
Tongji Medical College, Huazhong University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, Postoperative, run by Qin Zhang at 2 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 4 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 Xiao Ran, phd (15926207366, ranxiao1001@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: 7days). 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 9 Apr 2024.