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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07721038
Enrollment
400
Registered
2026-07-22
Start date
2026-07-20
Completion date
2028-12-31
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Health

Keywords

Tubeless anesthesia, double-lumen bronchial intubation, brain health

Brief 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 (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.

Interventions

None listed

Sponsors

Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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 * 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)

Exclusion criteria

* 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 * 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;

Design outcomes

Primary

MeasureTime frameDescription
Concentration of cognitive function biomarkers in the serum samples of 400 patientsBefore 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 patientsBefore 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 patientsBefore 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

Secondary

MeasureTime frameDescription
Anesthesia Record Format the end of the surgery (T2)Record the vital signs at the T2 time point
Case information system collectionBefore the start of the surgery (T1), and on the first day after the surgery (T3)Record the pulmonary function, chest X-ray or chest CT at time points T1 and T3
Postoperative follow-up recordsthrough study completion, an average of 1 yearRecord the time of chest tube removal after surgery

Countries

China

Contacts

CONTACTLan Lan, PHD
lanlan@gzhmu.edu.cn+8602083062566
CONTACTFengfa Yang, BS
yff18312377134@163.com+8602083062566
STUDY_DIRECTORLan Lan, PHD

The First Affiliated Hospital of Guangzhou Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026