The Impact of Multimodal Brain Monitoring on Postoperative Outcomes in Elderly Patients Undergoing Major Abdominal Surgery

Impact of Multimodal Brain Monitoring Under General Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Major Abdominal Surgery: A Multicenter, Prospective, Single-blind, Randomized Controlled Study

The purpose of this clinical trial is to investigate the effect of multimodal brain monitoring under general anesthesia on postoperative outcomes in elderly patients undergoing abdominal surgery.The research hypothesis is that multimodal brain monitoring under general anesthesia can reduce the incidence of postoperative composite complications and improve postoperative outcomes in elderly patients undergoing major abdominal surgery.

Eligible patients will be randomly assigned in a 1:1 ratio to the Multimodal Brain Monitoring under General Anesthesia Group (MBMGA group) and the Bispectral Index Monitoring under General Anesthesia Group (BIS group). The primary outcome is the postoperative composite complication rate . Secondary outcomes include intraoperative hyperglycemia, adverse events during anesthesia induction and maintanance, changes in blood pressure and heart rate, intraoperative hypotension, the dosage of perioperative anesthetics and vasoactive drugs, changes in serum cortisol, cardiac troponin I, blood creatinine (Cr) level, extubation time and awake time, the rate of transferring to ICU or AICU, The time to first use analgesia pump and the cumulative dose of postoperative oxycodone, systemic complications, hospitalization time, first exhaust time , first oral intake time, rate of second surgery and mortality within 30 days postoperatively.

Participants will:

1. Undergo routine preoperative fasting for 6-8 hours;
2. Prior to anesthesia induction, cooperate with the establishment of intravenous access, arterial catheterization, monitoring of physiological parameters, blood sample collection, and receive fluid preloading;
3. During surgery, for patients in the MBMGA group , propofol and remifentanyl will be adjusted according to multimodal brain monitoring indices (WLi and PTi), while for patients in the BIS group, only propofol will be adjusted based on bispectral index and remifentanyl will be adjusted according to anesthesiologists' experience; simultaneously, vital signs, including respiration, body temperature, fluid therapy, blood pressure, and heart rate regulation, will be monitored and managed.
4. After surgery, endotracheal tubes will be removed once extubation criteria are met, and patients will be transferred to the PACU, where they will receive routine monitoring and will be discharged from the PACU upon meeting corresponding scoring criteria;
5. Participates in follow-ups on the day of surgery and for 1-30 days postoperatively, during which investigators will record the primary outcome and secondary outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, General; Major Abdominal Surgeries
• Intervention / Treatment: Other: Multimodal brain monitoring guided anesthesia; Other: Bispectral Index(BIS) monitoring guided anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 368
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tianlong Wang, Doctor; Phone Number: 0086139 1052 5304; Email: w_tl5595@hotmail.com
• Study Contact Backup: Name: Wei Xiao, Doctor; Phone Number: 008613810971299; Email: kitten15@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking University International Hospital
      • Contact: Lan Yao, Doctor; Phone Number: 008613671010819; Email: yaolan@pkuih.edu.cn
      • Principal Investigator: Lan Yao
    • Beijing, Beijing Municipality, China, 10053
      • Xuanwu Hospital Capital Medical University
      • Contact: Wei Xiao, Doctor; Phone Number: 008613810971299; Email: kitten15@126.com
      • Principal Investigator: Tianlong Wang
      • Sub-Investigator: Wei Xiao
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
      • Principal Investigator: Jianjun Yang
      • Contact: Jianjun Yang, Doctor; Phone Number: 008613357739238; Email: jianjunyang1971@163.com
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
      • Contact: Ailin Luo, Doctor; Phone Number: 008613507122565; Email: alluo@tjh.tjmu.edu.cn
      • Principal Investigator: Ailin Luo

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Aged ≥65 years, regardless of gender; Scheduled for elective abdominal surgery with general anesthesia duration (from anesthesia induction to surgery completion) ≥ 2 hours; American Society of Anesthesiologists (ASA) physical status classification of I-III; Body mass index (BMI) of 18.5-29.9 kg/m²; Postoperative hospital stay expected to exceed 72 hours; Compliant with ethical standards, with voluntary signed informed consent.

Exclusion Criteria:

Severe cardiovascular diseases, including:

History of myocardial infarction within the past 6 months; Bradycardia (resting heart rate <50 beats/min); Uncontrolled hypertension (sitting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during screening); Sitting systolic blood pressure ≤90 mmHg during screening; History of severe valvular heart disease; Uncontrolled severe respiratory infections: e.g., severe pneumonia, acute bronchitis.

Abnormal liver function: Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) ≥2.5×Upper Limit of Normal (ULN), Total Bilirubin (TBIL) ≥1.5×Upper Limit of Normal (ULN); Abnormal renal function: urea or blood urea nitrogen (BUN) ≥1.5×Upper Limit of Normal (ULN), serum creatinine >Upper Limit of Normal (ULN); Admission hemoglobin A1c (HbA1c) ≥6.5% or ≥2 fasting blood glucose measurements ≥180 mg/dl (10 mmol/L) and/or random blood glucose ≥200 mg/dL (≈11.1 mmol/L); Preoperative anemia (Hemoglobin [Hb] ≤90 g/L), thrombocytopenia (Platelet [PLT] ≤80×10⁹/L), hypoproteinemia (Albumin [Alb] ≤30 g/L); History of drug abuse and/or alcoholism within the past 2 years (alcoholism defined as daily average alcohol consumption >2 units, where 1 unit = 360 mL beer or 45 mL 40% ethanol liquor or 150 mL wine); Neurological diseases (e.g., stroke within 6 months, Alzheimer's disease, Parkinson's disease, mental disease, myasthenia gravis) or psychiatric disorders (e.g., schizophrenia, mania, bipolar disorder, delirium), history of long-term use of neuropsychiatric medications, or cognitive impairment; Allergy or contraindication to study medications; Patients refusing or unable to cooperate with the study; Scheduled for pancreatic surgery; Other conditions deemed inappropriate for participation by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal Brain Monitoring Guided Anesthesia Group(MBMGA Group); The dosage of propofol is adjusted to maintain WLi in the range of 40-70. While the dosage of remifentanil is adjusted to maintain PTi in the range of 40-70. When intraoperative pain stimulation suddenly increases ( PTi > 70 ) and lead to increased heart rate and elevated blood pressure, remifentanil 0.5-1 μg / kg will be intravenously injected and observed for 1 min. If PTi still is > 70, remifentanil 0.5-1 μg / kg will be added again until PTi reached 40-70.	Other: Multimodal brain monitoring guided anesthesia; During the anesthesia induction phase, the dosage administration is guided by the goal of reducing PTi to the range of 40-70, and tracheal intubation is performed when both PTi and WLI are within 40-70. In the anesthesia maintenance phase, the propofol dosage is adjusted according to the WLI value to maintain WLI within 40-70, while the remifentanil dosage is adjusted based on the PTi value to keep PTi within 40-70. In the event of sudden increased intraoperative pain stimulation (PTi > 70) accompanied by tachycardia and hypertension, an intravenous bolus of remifentanil at 0.5-1 μg/kg is administered; after 1 minute of observation, if PTi remains > 70, an additional 0.5-1 μg/kg of remifentanil is given until PTi is brought back to the 40-70 range.
Active Comparator: Bispectral Index (BIS) Monitoring Guided Anesthesia Group( BIS Group); The dosage of propofol is adjusted according to the value of BIS, and the BIS is maintained in the range of 40 ~ 60. The dosage of remifentanil is adjusted according to the experience of anesthesiologists. The intraoperative remifentanil dosage will be maintained between 0.1 μg/kg/min and 0.3μg/kg/min.When it is highly suspected that the sudden increase of pain stimulation during operation leads to the increase of heart rate and blood pressure, remifentanil 0.5 ~ 1 μg / kg will be given intravenously for 1 min. If the heart rate and blood pressure level don't improve, remifentanil 0.5 ~ 1 μg / kg is added again until the heart rate and blood pressure have a downward trend and return to the level before the increase.	Other: Bispectral Index(BIS) monitoring guided anesthesia; During the anesthesia induction phase, the dosage administration is guided by the goal of reducing BIS to the range of 40-60, with remifentanil supplemented based on clinical experience. In the anesthesia maintenance phase, the propofol dosage is adjusted according to BIS values to maintain BIS within 40-60, while the remifentanil dosage is adjusted based on anesthesiologists' experience. When there is a high suspicion of sudden tachycardia and hypertension induced by increased intraoperative pain stimulation, an intravenous bolus of remifentanil at 0.5-1 μg/kg is administered; after 1 minute of observation, if heart rate and blood pressure show no improvement, an additional 0.5-1 μg/kg of remifentanil is given until there is a downward trend in heart rate and blood pressure and they return to pre-stimulation levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Composite Complication	The incidence of ≥ 1 complication occurred from the extubation to the 30 th day postoperatively The definition of postoperative composite complications refers to the rate of occurrence of one or more complications from the time of anesthesia extubation to postoperative day 7 (or the day of discharge) and within 30 days after surgery. Postoperative complications are defined as adverse events of Clavien Dindo grade II or higher occurring in any system from postoperative day 1 to day 7 (or the day of discharge) and within 30 days after surgery.	From post-extubation to postoperative Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative stress-induced hyperglycemia	Intraoperative stress hyperglycemia is defined as: A condition diagnosed when a patient meeting all the following criteria: Preoperative glycemic status: Two or more fasting blood glucose measurements < 126 mg/dL (≈7.0 mmol/L) or Random blood glucose < 200 mg/dL (≈11.1 mmol/L) during hospitalization, With concurrent HbA1c < 6.5%; Intraoperative finding: Highest blood glucose level ≥ 140 mg/dL (≈7.8 mmol/L) when measured at: 1 hour after intubation and/or Upon completion of surgery.	From anesthesia induction to skin closure, assessed up to 5 minutes after surgery
Incidence of intraoperative composite adverse events	Observe and record the incidence of intraoperative composite adverse events . Adverse events include but are not limited to: Cardiovascular Complications:HypotensionHypertensionSevere Arrhythmia ④Acute Myocardial IschemiaAcute Myocardial Infarction ⑥Acute Pulmonary EmbolismAcute Heart Failure ⑧Deep Vein Thrombosis; Respiratory Complications:PneumoniaAcute Respiratory Distress Syndrome (ARDS)Pulmonary Edema ④Respiratory Failure ⑤Bronchospasm⑥Atelectasis⑦Pleural Effusion; Neurological Complications:①Intraoperative Awareness②Acute Stroke; Renal Complications:Acute Kidney Injury (AKI) ②Acute Renal Failure (ARF)	during operation, assessed up to 5 minutes after surgery
Blood pressure change immediately after intubation	Record blood pressure before induction and immediately after completion of intubation, and calculate the magnitude of change.	at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation
Duration of intraoperative hypotension	Parameters to be recorded: Duration of intraoperative hypotension； Hypotension is defined as: Mean arterial pressure < 65 mmHg or decrease of mean arterial pressure > 20% from preoperative baseline value.	From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery
Total pintraoperative anesthetic/vasoactive drug dosages	Record the dosages of all medications administered during the intraoperative period, including but not limited to: General anesthetics: Propofol, Remifentanil, Sufentanil, Oxycodone Vasoactive agents: Norepinephrine; Esmolol; Urapidil; Atropine; Ephedrine; Phenylephrine	from the anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery
Serum cortisol levels before surgery and 24 hours postoperatively	Measure serum cortisol concentrations at the following time points: Preoperatively and 24 hours postoperatively	From before surgery and 24 hours post-operation
Durations from drug cessation to awake/extubation	Duration from anesthesia discontinuation to awake and duration from anesthesia discontinuation to extubation	From drug cessation to awake/extubation , assessed up to 2 hours after entering post-anesthsia care unit
Rate of postoperative Intensive Care Unit/Anesthesia Intensive Care Unit transfer	The ratio of postoperative patients requiring transfer to either the Anesthesia Intensive Care Unit or Intensive Care Unit for any clinical indication, to the total number of surgical patients during the same period.	From the end of surgery to Discharge, assessed up to 2 weeks after surgery
Duration to first patient controlled intravenous analgesia pump use	The duration from the end of surgery until the first activation of the patient controlled intravenous analgesia pump	From the initiation of patient controlled intravenous analgesia pump use to the discontinuation of analgesic pump use, assessed up to 3 days after surgery
Incidence of complications in other organ systems during the follow-up period except stress induced hyperglycemia	Follow-up assessments will be performed by a single blinded and certified anesthesia practitioner at postoperative days 1-7 and day 30, with documentation of complications involving: Cardiovascular system； Respiratory system； Digestive system； Nervous system； Urinary system； Infection-related complications,such as wound infection Postoperative complications are defined as adverse events of Clavien Dindo grade II or higher occurring in any system from postoperative day 1 to day 7 (or the day of discharge) and within 30 days after surgery.	From the start of surgery to 30 days post-operation
Length of hospital stay	the duration of patient stay in hospital	From patient admission to discharge, assessed up to 2 weeks after surgery
Rate of second operation	Observation and record the rate of secondary surgeries	From immediately after surgery to 30 days postoperatively
Mortality within 30-day postoperatively	Record the mortality within 30 days postoperatively.	From immediately after surgery to 30 days postoperatively
Incidence of acute myocardial injury	Measure blood cardiac troponin I level at the following time points: Preoperatively and 24 hours postoperatively, measurement of cardiac troponin I exceeds the 99th percentile upper reference limit	From anesthesia induction to 24 hours after surgery
Incidence of acute kidney injury	Measure blood creatinine level at the following time points: 1 day before surgery, and 24 hours postoperatively;Acute kidney injury was defined according to the KDIGO criteria as the presence of any of the following: (1) an increase in serum creatinine by ≥26.5 μmol/L (0.3 mg/dL) within 48 hours; (2) an increase in serum creatinine to ≥1.5 times baseline within the previous 7 days; or (3) a urine volume <0.5 mL/kg/h for 6 consecutive hours.	From anesthesia induction to 24 hours after surgery
Incidence of postoperative surgical site infection	surgical site infection refers to the proportion of surgical cases with surgical site infection (SSI) occurring from after surgery to before discharge, relative to the total number of surgical procedures performed on hospitalized patients during the same period. Postoperative wound infection is defined as an infection related to the surgical procedure and occurring near the surgical site within 30 days after surgery. Postoperative wound infections include: superficial incisional SSI, deep incisional SSI, and organ/space SSI.	From immediately after surgery to 30 days postoperatively
Heart rate change immediately after intubation	Record heart rate before induction and immediately after completion of intubation, and calculate the magnitude of change.	at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation
Duration to postoperative first flatus time	Duration to postoperative first flatus time	From the end of surgery to 7 days after surgery
Duration to postoperative first oral intake	Duration to postoperative first oral intake	From the end of surgery to 7 days after surgery
Minimum intraoperative mean arterial pressure	Parameters to be recorded: Minimum intraoperative mean arterial pressure ；	From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery
Incidence of hypotension.	Parameters to be recorded: Incidence of hypotension； Hypotension is defined as: Mean arterial pressure < 65 mmHg or decrease of mean arterial pressure > 20% from preoperative baseline value.	From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery
Durations of post-anesthesia care unit stay	Duration of post-anesthesia care unit stay	From entering post-anesthesia care unit to post-anesthesia care unit discharge, assessed up to 2 hours after entering post-anesthsia care unit
Cumulative postoperative oxycodone dosage	Cumulative postoperative oxycodone dose	From the initiation of patient controlled intravenous analgesia pump use to the discontinuation of analgesic pump use, assessed up to 3 days after surgery
The duration of intraoperative deep sedation	The duration of intraoperative wavelet index below 40 or Bispectral Index below 40	from anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery
The duration of intraoperative inadequate analgesia	The duration of intraoperative pain threshold index higher than 70	from anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery
Scores of Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms at 72 hours after surgery	Scores of Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms at 72 hours after surgery, Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms is a scoring system to evaluate the postoperative gastrointestinal function, if the score is higher than 6, it indicating gastrointestinal dysfunction.	at 72 hours after surgery

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Tongji Hospital; Peking University International Hospital; The First Affiliated Hospital of Zhengzhou University
• Investigators: Principal Investigator: Tianlong Wang, Doctor, Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• Lewis SR, Pritchard MW, Fawcett LJ, Punjasawadwong Y. Bispectral index for improving intraoperative awareness and early postoperative recovery in adults. Cochrane Database Syst Rev. 2019 Sep 26;9(9):CD003843. doi: 10.1002/14651858.CD003843.pub4.
• Lau CS, Chamberlain RS. Enhanced Recovery After Surgery Programs Improve Patient Outcomes and Recovery: A Meta-analysis. World J Surg. 2017 Apr;41(4):899-913. doi: 10.1007/s00268-016-3807-4.
• American Diabetes Association Professional Practice Committee. 16. Diabetes Care in the Hospital: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S321-S334. doi: 10.2337/dc25-S016.
• You J, Chen X, Rong Y, Pan S, Liu T, Xie Y. Application value of different frailty assessment tools in older patients undergoing major abdominal surgery. Exp Gerontol. 2025 Oct 1;209:112852. doi: 10.1016/j.exger.2025.112852. Epub 2025 Jul 29.
• Trocheris-Fumery O, Flet T, Scetbon C, Tarpin P, Meynier J, Badaoui R, De Broca B, Sabbagh C, Regimbeau JM, De Sousa P, Foulon A, Josse E, Dupont H, Bar S, Abou-Arab O. Early Use of Norepinephrine in High-risk Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial. Anesthesiology. 2025 Nov 1;143(5):1160-1170. doi: 10.1097/ALN.0000000000005704. Epub 2025 Aug 4.
• Zhang Y, Yan R, Kurexi A, Yuan T, Taati Z, Mijiti M, Li D, Wei F. The relationship between preoperative SPPB scores and 30-day postoperative pulmonary complications in elderly patients undergoing elective major abdominal surgery. BMC Surg. 2025 Oct 28;25(1):507. doi: 10.1186/s12893-025-03260-6.
• Bieze M, McGinn R, Berrio-Valencia M, Talarico R, Martel G, McCluskey SA, McIsaac DI. Temporal trends in postoperative outcomes after major abdominal surgery: a population-based cohort study. Br J Anaesth. 2026 Jan;136(1):237-246. doi: 10.1016/j.bja.2025.08.030. Epub 2025 Oct 23.
• Gameiro J, Neves JB, Rodrigues N, Bekerman C, Melo MJ, Pereira M, Teixeira C, Mendes I, Jorge S, Rosa R, Lopes JA. Acute kidney injury, long-term renal function and mortality in patients undergoing major abdominal surgery: a cohort analysis. Clin Kidney J. 2016 Apr;9(2):192-200. doi: 10.1093/ckj/sfv144. Epub 2016 Jan 18.
• Teixeira C, Rosa R, Rodrigues N, Mendes I, Peixoto L, Dias S, Melo MJ, Pereira M, Bicha Castelo H, Lopes JA. Acute kidney injury after major abdominal surgery: a retrospective cohort analysis. Crit Care Res Pract. 2014;2014:132175. doi: 10.1155/2014/132175. Epub 2014 Feb 24.
• Zhang W, Cheng Y, Zhang L, Wei Y, Xie H, Huang J. Association between emergence delirium and brain status parameters in children undergoing general anesthesia: A prospective observational study. Paediatr Anaesth. 2024 Feb;34(2):130-137. doi: 10.1111/pan.14779. Epub 2023 Oct 3.
• Zhang JW, Lv ZG, Kong Y, Han CF, Wang BG. Wavelet and pain rating index for inhalation anesthesia: A randomized controlled trial. World J Clin Cases. 2020 Nov 6;8(21):5221-5234. doi: 10.12998/wjcc.v8.i21.5221.
• Funcke S, Pinnschmidt HO, Wesseler S, Brinkmann C, Beyer B, Jazbutyte V, Behem CR, Trepte C, Nitzschke R. Guiding Opioid Administration by 3 Different Analgesia Nociception Monitoring Indices During General Anesthesia Alters Intraoperative Sufentanil Consumption and Stress Hormone Release: A Randomized Controlled Pilot Study. Anesth Analg. 2020 May;130(5):1264-1273. doi: 10.1213/ANE.0000000000004388.
• Wu L, Wang S, Wang Y, Zhang K, Bai J, Zheng J. Prediction of Hemodynamic Reactivity by Electroencephalographically Derived Pain Threshold Index in Children Undergoing General Anesthesia: A Prospective Observational Study. J Pain Res. 2019 Dec 3;12:3245-3255. doi: 10.2147/JPR.S231596. eCollection 2019.
• Shen H, Wang S, Zhang C, Gao W, Cui X, Zhang Q, Lang Y, Ning M, Li T. Association of hyperglycemia ratio and ventricular arrhythmia in critically ill patients admitted to the intensive care unit. BMC Cardiovasc Disord. 2023 Apr 28;23(1):215. doi: 10.1186/s12872-023-03208-9.
• Yu Y, Wang H, Wei L, Gao Y, Yan N, Chu J, Li H. Assessing the use of the Index of Consciousness (IoC) as a monitoring tool for the sedative effects of ciprofol during general anesthesia induction: a prospective observational study. Perioper Med (Lond). 2025 Jan 6;14(1):1. doi: 10.1186/s13741-024-00484-7.
• Chung CKE, Poon CCM, Irwin MG. Peri-operative neurological monitoring with electroencephalography and cerebral oximetry: a narrative review. Anaesthesia. 2022 Jan;77 Suppl 1:113-122. doi: 10.1111/anae.15616.
• Fu G, Xu L, Chen H, Lin J. State-of-the-art anesthesia practices: a comprehensive review on optimizing patient safety and recovery. BMC Surg. 2025 Jan 20;25(1):32. doi: 10.1186/s12893-025-02763-6.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Linyanshen[2025]075-004-xz-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: One year after results publicated
• IPD Sharing Access Criteria: Contacting the corresponsible author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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