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

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 Overview

• Status: Not yet recruiting
• Conditions: Brain Health

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Lan Lan, PHD; Phone Number: +8602083062566; Email: lanlan@gzhmu.edu.cn
• Study Contact Backup: Name: Fengfa Yang, BS; Phone Number: +8602083062566; Email: yff18312377134@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Lan Lan, PHD; Phone Number: +8602083062566; Email: lanlan@gzhmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia Record Form	Record the vital signs at the T2 time point	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	Before the start of the surgery (T1), and on the first day after the surgery (T3)
Anesthesia Record Form	Record the intraoperative conditions	During the operation
Postoperative follow-up records	Record the time of chest tube removal after surgery	through study completion, an average of 1 year
Postoperative follow-up records	the usage of postoperative analgesic drugs	through study completion, an average of 1 year
Postoperative follow-up records	the postoperative hospital stay	through study completion, an average of 1 year
Postoperative follow-up records	the total hospitalization cost	through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative follow-up records	Record the occurrence of adverse events during the perioperative period	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Guangzhou Medical University
• Investigators: Study Director: Lan Lan, PHD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 19, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 19, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: brain health; Tubeless anesthesia; double-lumen bronchial intubation
• Other Study ID Numbers: ES-2025-216-02; GMUCR2025-02011 (Other Grant/Funding Number: Guangzhou Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient clinical data
• IPD Sharing Access Criteria: The data can be obtained by email from Lan Lan (Email: lanlan@gzhmu.edu.cn) for clinical requirements.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No