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临床试验/NCT06541483
NCT06541483尚未招募不适用

A Multicenter Clinical Study of Ultra-Fast-Track Cardiac Anesthesia in Minimally Invasive Cardiac Surgery for Valvular Heart Disease

Zhejiang Provincial People's Hospital0 个研究点目标入组 1,200 人开始时间: 2024年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,200
主要终点
Post-operative hospitalization

研究概览

简要总结

The goal of this clinical trial is to evaluate the clinical effects of ultra-fast-track anesthesia (UFTA) for minimally invasive cardiac surgery (MICS) in adults. It will also learn about the safety and feasibility of Ultra-Fast-Track cardiac surgery(UFTCA).The main questions it aims to answer are:Does UFTCA promote rapid postoperative recovery, reduce postoperative complications and perioperative mortality, and improve the quality of mid- and long-term survival.And does it improve patient satisfaction and reduce healthcare costs.

Participants will receive homogenized perioperative management in the cardiac ward, extracorporeal circulation, and postoperative ICU, except for anesthesia extubation time.Furthermore,Participants need complete quality of life scales at 30 days, 90 days, six months, and one year after surgery, separately.

Participants in this study are adults who required elective minimally invasive heart valve surgery under extracorporeal circulation.This study will be able to promote rapid recovery while reducing the associated costs and the financial burden on participants.Retrospective big data analysis of perioperative clinical characteristics of patients undergoing minimally invasive heart valve surgery to establish a risk warning model and develop a perioperative management program. The investigators then conducts a randomized group trial comparing the similarities and differences between conventional general anesthesia(CGA) and ultra-fast-track cardiac anesthesia(URTCA) to demonstrate the effectiveness and safety of UFTA in MICS.Finally, building expert consensus.

详细描述

This study was divided into two parts:The first part is retrospective data collection and organization, screening risk factors to establish an early warning model to improve the perioperative management program, and the other part is conducted using a randomized controlled trial to evaluate the effectiveness, safety and benefit of the perioperative management program of ultra-fast-track anesthesia(UFTA) for minimally invasive heart valve surgery. The specific program is as follows:

Part I

  1. Establishment of an information collection platform Log in to the platform for electronic data entry and retain the paper version of the CaseReportForm(CRF)
  2. Retrospective data collection Relying on the National Head Medical Center for Cardiac Surgery, 5000 perioperative case data of minimally invasive heart valve surgery patients were counted to obtain the perioperative clinical characteristics of Chinese adult minimally invasive heart valve surgery patients.
  3. Screening for risk factors Statistical analysis of risk factors affecting perioperative ultra-fast-track anesthesia delivery and postoperative complications
  4. Establishment of early warning model Combining age stratification, surgical mode stratification and general characteristics, establish an early warning model to improve the perioperative management protocol of ultra-fast channel anesthesia for minimally invasive heart valve surgery.

Part II Recruitment of participants for a prospective randomized controlled trial

  1. Participants Patients undergoing elective minimally invasive adult heart valve surgery will be selected after completion of history taking, physical examination, preoperative laboratory and ancillary investigations, preoperative health and quality of life questionnaires, and frailty assessment of their physical condition, and will be confirmed to be free of any one of the "Exclusion Criteria" and to meet any one or more of the "Inclusion Criteria". Those who fulfill any one of the "Exclusion Criteria" and more than one of the "Inclusion Criteria" will be given a screening number. After completing the basic information and preoperative medications, the participant signed the informed consent form. If either the participant or the family member does not agree to participate in the study, the participant will only be given a screening number and the study will end here.
  2. Randomized grouping Participants who were included to meet the criteria were randomly divided into the ultra-fast-track anesthesia group (UFTCA) and the conventional general anesthesia group (CGA), and the homogenized perioperative management of the extracardiac ward, extracorporeal circulation, and postoperative ICU was implemented, except for anesthesia resuscitation methods.
  3. Anesthesia management 3.1 Preoperative Preoperative education, nutritional support, fasting and abstinence from food and drink, prophylactic multimodal analgesia (preoperative oral pregabalin 150 mg and acetaminophen 1000 mg) 3.2 Intraoperative Anesthesia mode: tracheal intubation general anesthesia plus nerve block anesthesia Induction of anesthesia: intravenous slow push etomidate fat milk injection 0.15 mg/kg, propofol injection 0.5~1.0 mg/kg, sufentanil citrate injection 0.4~0.5 mg/kg, rocuronium bromide 0.6~0.8 mg/kg, to be the patient's consciousness disappeared, to be the mask pressurized denitrification of oxygen for 3~5 minutes, muscle relaxation after the complete effect of the laryngoscopy under the direct visualization The patient was intubated, fixed, and mechanically ventilated, and the respiratory parameters were set as follows: Fraction of inspiratory oxygen concentration (FiO2): 50~80%, tidal volume (VT): 6~8 ml/kg, respiratory rate (RR): 10~12 times/min, Inhalation-exhalation ratio (I:E): 1:2, Maintain End-tidal CarbonDioxidePartialPressure (PetCO2) at 35~45 mmHg.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 and ≤80 years
  • American Society of Anaesthesiologists (ASA) class I-III
  • New York Heart Association (NYHA) cardiac class III or below
  • Preoperative inspired air pulse oximetry (SpO2) ≥95%
  • Ejection fraction (EF) ≥ 40%
  • No contraindications to nerve blocks

排除标准

  • Patient's refusal to participate
  • Severe communication disorders
  • Severe disorders of coagulation with spontaneous bleeding tendency
  • Long-term application of opioid analgesics
  • Pulmonary hypertension (mean pulmonary artery pressure ≥55 mmHg)
  • People who need artificial ventilation
  • Allergy to dexmedetomidine and ropivacaine
  • Complex aortic root surgery such as root widening

结局指标

主要结局

Post-operative hospitalization

时间窗: From the end of surgery to discharge, approximately 1 week

Length of postoperative hospitalization

tracheal tube extubation time

时间窗: From the end of the operation to the removal of the tracheal tube,up to 3 days

Time interval for tracheal extubation

complication

时间窗: From the end of surgery to 1 year after surgery

Acute kidney injury, coma, acute respiratory distress syndrome (ARDS), postoperative atrial fibrillation, pericardial tamponade, gastrointestinal complications, death, cardiac arrest, heart block, and permanent stroke

ICU length of stay

时间窗: From entry to exit from ICU,approximately 3 days

Length of time participants stayed in the ICU

Length of hospitalization

时间窗: From admission to discharge, approximately 2 weeks

Length of time participants stayed in the hospital

Unscheduled events

时间窗: From the end of surgery to 30 days after surgery

reintubation, reoperation,ICU readmission, 30-day readmission

The 36-Item Short Form Health Survey(SF-36)

时间窗: up to 1 year postoperative

minimum values:0 maximum values:100 higher scores mean a better outcome

expenditure

时间窗: From admission to discharge, approximately 2 weeks

Total cost of treatment

次要结局

  • Postoperative opioid dosage(From the end of surgery to discharge,approximately 1 week)
  • Application of vasoactive drugs(intraoperative)
  • Intraoperative opioid dosages(intraoperative)
  • VAS score(72 hours post-surgery)
  • Thoracic drainage within 24 hours(24 hours post-surgery)
  • Thoracic drain removal time(From the end of surgery to chest drain removal, approximately 3 days)
  • Bowel evacuation time(Time from end of surgery to first bowel evacuation, approximately 2 days)
  • Time from end of surgery to removal from operating room(From end of surgery to removal from operating room, up to 1 hour)
  • Total Thoracic Drainage(From the end of surgery to chest drain removal, approximately 3 days)
  • coagulation(One day before to the next day after surgery,72 hours)
  • myocardial injury(One day before to the next day after surgery,72 hours)
  • neurological injury(One day before to the next day after surgery,72 hours)
  • Patient satisfaction(up to 1 year after discharge from hospital)
  • oxygenation index(From admission to discharge, approximately 2 weeks)
  • time out of bed(Time from end of surgery to first time out of bed, approximately 2 days)
  • Inflammatory levels(From the start of anesthesia induction to 48 hours after extubation)
  • Anesthesia costs(Until 1 hours post-surgery)

研究者

申办方类型
Other
责任方
Sponsor

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