Brain HealthNCT07721038
A Prospective Clinical Study Observed the Effects of Tubeless Anesthesia Method That Preserves Spontaneous Breathing and the Double-lumen Bronchial Intubation on the Brain Health During the Perioperative Period
An observational study of Brain Health, run by Guangzhou Medical University at 1 site in China.
Trial summary
This project conducts a prospective cohort study. By using multiple questionnaire survey methods such as the Pittsburgh Sleep Quality Index (PSQI) electronic wristband, QOR15, Pain Catastrophizing Scale (PCS), European Five-Dimensional Health Scale (EQ-5D), Revised American Pain Society Patient Follow-up Questionnaire… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Health
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 31 Dec 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent elective non-anatomic partial lung resection surgery at the First Affiliated Hospital of Guangzhou Medical University
Who may be able to join
- Patient age: 18 - 75 years old
- Patients meeting the standards of the American Society of Anesthesiologists (ASA) I-III grade and the New York Heart Association (NYHA) I-II class
- Body Mass Index (BMI) < 30 kg/m2
- Intraoperative blood loss less than 300 ml
- No severe cardiac or pulmonary dysfunction [first-second forced vital capacity (FEV1%) predicted value] > 50%, ejection fraction (EF) > 50%
- No contraindications related to paravertebral nerve block and intercostal nerve block
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- Able to sign the informed consent form and possess communication, reading and writing abilities
- Postoperative hospital stay of at least one day
- No preoperative sleep disorders, no cognitive dysfunction (PSQI ≤ 10 points, PCS ≤ 38 points, MMSE > 27 points)
Who cannot join
- Already diagnosed with a mental disorder or had a preoperative Mini-Mental State Examination (MMSE) score of less than 27
- History of opioid abuse
- Patients who were admitted to the ICU after surgery
- Have severe cardiovascular, respiratory diseases
- Experienced critical rescue during or after the surgery
- Complicated with coagulation dysfunction, severe hypoxia or hypercapnia, or liver and kidney dysfunction
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- Difficult airway management
- Changed anesthetic agent or surgical plan
- Severe lacunar cerebral infarction, ischemic stroke or other neurological diseases
- Changed anesthetic agent or surgical plan during the surgery;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Lan Lan, PHD, +8602083062566, lanlan@gzhmu.edu.cn
About this study
Official title: Tubeless Anesthesia With Preserved Spontaneous Breathing and the Construction of a Perioperative Brain Health Safety System for Thoracic Surgery Patients Study 2: A Prospective Clinical Study Observing the Impact of Two Anesthesia Techniques-Tubeless With Preserved Spontaneous Breathing Versus Double-Lumen Endotracheal Intubation-on Perioperative Brain Health
This project conducts a prospective cohort study. By using multiple questionnaire survey methods such as the Pittsburgh Sleep Quality Index (PSQI) electronic wristband, QOR15, Pain Catastrophizing Scale (PCS), European Five-Dimensional Health Scale (EQ-5D), Revised American Pain Society Patient Follow-up Questionnaire (APS-POQ-R), Mini-Mental State Examination (MMSE), as well as perioperative stress and related indicators, hypothalamic-pituitary-adrenal axis (HPA) endocrine indicators, sublingual microcirculation, electroencephalogram, etc., comprehensive assessment is made of the correlations between the two different anesthesia methods of Tubeless retention of spontaneous breathing and double-lumen bronchial intubation and postoperative sleep, chronic pain and cognitive function, to construct a perioperative brain health safety system to improve prognosis; at the same time, optimize the perioperative sedation and analgesia plan and promote the postoperative brain health recovery of patients.
- Conditions
- Brain Health
- Keywords
- Tubeless anesthesia, double-lumen bronchial intubation, brain health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| tubeless group | Patients undergoing elective non-anatomic partial lung resection surgery using the Tubeless technique for maintaining spontaneous breathing anesthesia | |
| double-lumen bronchial intubation group | Patients undergoing elective non-anatomic lung segmentectomy surgery using the double-lumen bronchial tube anesthesia method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of cognitive function biomarkers in the serum samples of 400 patients
At time points T1, T2, and T3, 5 ml of peripheral venous blood was collected to test the biological indicators of postoperative cognitive function.
Measured: Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)
Concentrations of HPA axis-related indicators in the serum samples of 400 patients
At the TI-T2 time point, 5 ml of peripheral venous blood was collected for the detection of HPA axis-related indicators.
Measured: Before the start of the surgery (T1), at the end of the surgery (T2)
The concentrations of laboratory test indicators in the serum samples of 400 patients
Record the laboratory test indicators at time points T1 and T3
Measured: Before the start of the surgery (T1), and on the first day after the surgery (T3)
Secondary outcomes (7)
Anesthesia Record Form
Record the vital signs at the T2 time point
Measured: at the end of the surgery (T2)
Case information system collection
Record the pulmonary function, chest X-ray or chest CT at time points T1 and T3
Measured: Before the start of the surgery (T1), and on the first day after the surgery (T3)
Anesthesia Record Form
Record the intraoperative conditions
Measured: During the operation
Postoperative follow-up records
Record the time of chest tube removal after surgery
Measured: through study completion, an average of 1 year
Postoperative follow-up records
the usage of postoperative analgesic drugs
Measured: through study completion, an average of 1 year
Postoperative follow-up records
the postoperative hospital stay
Measured: through study completion, an average of 1 year
Postoperative follow-up records
the total hospitalization cost
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain HealthStudies 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
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengfa Yang, Guangzhou Medical University
- Investigators
- Lan Lan, PHD, Study director, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721038
- Sponsor's protocol ID
- ES-2025-216-02
- Other IDs
- GMUCR2025-02011
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient clinical data
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tubeless Anesthesia With Preserved Spontaneous Breathing and the Construction of a Perioperative Brain Health Safety System for Thoracic Surgery Patients Study 2: A Prospective Clinical Study Observing the Impact of Two Anesthesia Techniques-Tubeless With Preserved Spontaneous Breathing Versus Double-Lumen Endotracheal Intubation-on Perioperative Brain Health
- ClinicalTrials.gov ID
- NCT07721038
- Acronym / sponsor ID
- ES-2025-216-02
- Conditions
- Brain Health
- Keywords
- Tubeless anesthesia, double-lumen bronchial intubation, brain health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jul 2026 (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.
This project conducts a prospective cohort study. By using multiple questionnaire survey methods such as the Pittsburgh Sleep Quality Index (PSQI) electronic wristband, QOR15, Pain Catastrophizing Scale (PCS), European Five-Dimensional Health Scale (EQ-5D), Revised American Pain Society Patient Follow-up Questionnaire (APS-POQ-R), Mini-Mental State Examination (MMSE), as well as perioperative stress and related indicators, hypothalamic-pituitary-adrenal axis (HPA) endocrine indicators, sublingual microcirculation, electroencephalogram, etc., comprehensive assessment is made of the correlations between the two different anesthesia methods of Tubeless retention of spontaneous breathing and double-lumen bronchial intubation and postoperative sleep, chronic pain and cognitive function, to construct a perioperative brain health safety system to improve prognosis; at the same time, optimize the perioperative sedation and analgesia plan and promote the postoperative brain health recovery of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tubeless group | – | –Patients undergoing elective non-anatomic partial lung resection surgery using the Tubeless technique for maintaining spontaneous breathing anesthesia |
| double-lumen bronchial intubation group | – | –Patients undergoing elective non-anatomic lung segmentectomy surgery using the double-lumen bronchial tube anesthesia method |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent elective non-anatomic partial lung resection surgery at the First Affiliated Hospital of Guangzhou Medical University
Key inclusion criteria (9 listed)
- Patient age: 18 - 75 years old
- Patients meeting the standards of the American Society of Anesthesiologists (ASA) I-III grade and the New York Heart Association (NYHA) I-II class
- Body Mass Index (BMI) < 30 kg/m2
- Intraoperative blood loss less than 300 ml
- No severe cardiac or pulmonary dysfunction [first-second forced vital capacity (FEV1%) predicted value] > 50%, ejection fraction (EF) > 50%
Key exclusion criteria (10 listed)
- Already diagnosed with a mental disorder or had a preoperative Mini-Mental State Examination (MMSE) score of less than 27
- History of opioid abuse
- Patients who were admitted to the ICU after surgery
- Have severe cardiovascular, respiratory diseases
- Experienced critical rescue during or after the surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of cognitive function biomarkers in the serum samples of 400 patients
Time frame: Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)
At time points T1, T2, and T3, 5 ml of peripheral venous blood was collected to test the biological indicators of postoperative cognitive function.
Concentrations of HPA axis-related indicators in the serum samples of 400 patients
Time frame: Before the start of the surgery (T1), at the end of the surgery (T2)
At the TI-T2 time point, 5 ml of peripheral venous blood was collected for the detection of HPA axis-related indicators.
The concentrations of laboratory test indicators in the serum samples of 400 patients
Time frame: Before the start of the surgery (T1), and on the first day after the surgery (T3)
Record the laboratory test indicators at time points T1 and T3
7 secondary outcomes
Anesthesia Record Form
Time frame: at the end of the surgery (T2)
Case information system collection
Time frame: Before the start of the surgery (T1), and on the first day after the surgery (T3)
Anesthesia Record Form
Time frame: During the operation
Postoperative follow-up records
Time frame: through study completion, an average of 1 year
Postoperative follow-up records
Time frame: through study completion, an average of 1 year
Postoperative follow-up records
Time frame: through study completion, an average of 1 year
Postoperative follow-up records
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. Patient clinical data
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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.
Lan Lan, PHD study director
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Health, run by Guangzhou Medical University 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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 22 Jul 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lan Lan, PHD (+8602083062566, lanlan@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of cognitive function biomarkers in the serum samples of 400 patients (time frame: Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)). The study lists 3 primary outcomes in all. 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 22 Jul 2026.