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

NCT07721038 | Not Yet Recruiting DMC

• 2 other identifiers: ES-2025-216-02GMUCR2025-02011
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Health

Keywords

Tubeless anesthesia; double-lumen bronchial intubation; brain health

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  Before the start of the surgery (T1), and on the first day after the surgery (T3)

Secondary Outcomes (7)

• Anesthesia Record Form

  at the end of the surgery (T2)

• Case information system collection

  Before the start of the surgery (T1), and on the first day after the surgery (T3)

• Anesthesia Record Form

  During the operation

• Postoperative follow-up records

  through study completion, an average of 1 year

• Postoperative follow-up records

  through study completion, an average of 1 year

Other Outcomes (1)

• Postoperative follow-up records

  through study completion, an average of 1 year

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent elective non-anatomic partial lung resection surgery at the First Affiliated Hospital of Guangzhou Medical University

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangzhou Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patient's serum

Study Officials

• Lan Lan, PHD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Lan Lan, PHD

CONTACT

+8602083062566; lanlan@gzhmu.edu.cn

Fengfa Yang, BS

CONTACT

+8602083062566; yff18312377134@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 22, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Access Criteria: The data can be obtained by email from Lan Lan (Email: lanlan@gzhmu.edu.cn) for clinical requirements.

Locations

CN (1)