Multicentre Clinical Study of Ultra-Fast-Track Anaesthesia for Minimally Invasive Heart Valve Surgery

NCT06541483 | Not Yet Recruiting

• 1 other identifier: 099
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Valve Diseases; Enhanced Recovery After Surgery

Keywords

Ultra-fast-track Anesthesia; minimally invasive cardiac surgery

Outcome Measures

Primary Outcomes (8)

• tracheal tube extubation time

  Time interval for tracheal extubation

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

• ICU length of stay

  Length of time participants stayed in the ICU

  From entry to exit from ICU,approximately 3 days

• Post-operative hospitalization

  Length of postoperative hospitalization

  From the end of surgery to discharge, approximately 1 week

• Length of hospitalization

  Length of time participants stayed in the hospital

  From admission to discharge, approximately 2 weeks

• complication

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

  From the end of surgery to 1 year after surgery

• Unscheduled events

  reintubation, reoperation,ICU readmission, 30-day readmission

  From the end of surgery to 30 days after surgery

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

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

  up to 1 year postoperative

• expenditure

  Total cost of treatment

  From admission to discharge, approximately 2 weeks

Secondary Outcomes (17)

• Time from end of surgery to removal from operating room

  From end of surgery to removal from operating room, up to 1 hour

• Intraoperative opioid dosages

  intraoperative

• VAS score

  72 hours post-surgery

• Postoperative opioid dosage

  From the end of surgery to discharge,approximately 1 week

• Application of vasoactive drugs

  intraoperative

Study Arms (2)

Ultra-Fast-Track Cardiac Anesthesia(UFTCA)

EXPERIMENTAL

The researchers implemented an ultra-fast-track anesthesia protocol, and the tracheal tube was removed immediately or within 1 hour of awakening at the end of the operation.

Procedure: Ultra-Fast-Track Cardiac Anesthesia(UFTCA)

conventional general anesthesia (CGA)

OTHER

The researcher implemented a conventional anesthesia protocol, and participants were not extubated at the end of the procedure and were admitted to the ICU under anesthesia with an endotracheal tube.

Procedure: conventional general anesthesia (CGA)

Interventions

Ultra-Fast-Track Cardiac Anesthesia(UFTCA) PROCEDURE

(UFTCA)The researcher removed the endotracheal tube either immediately or within 1 hour of the end of the procedure.

Ultra-Fast-Track Cardiac Anesthesia(UFTCA)

conventional general anesthesia (CGA) PROCEDURE

(CGA)The researcher not extubated at the end of the operation and were admitted to the ICU under anesthesia with an endotracheal tube.

conventional general anesthesia (CGA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead
• Beijing Anzhen Hospital: collaborator
• Fudan University: collaborator
• Wuhan Asia Heart Hospital: collaborator
• Tianjin Chest Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Xiangya Hospital of Central South University: collaborator
• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: collaborator
• Guangdong Provincial People's Hospital: collaborator

Related Publications (17)

• Krzych L, Kucewicz-Czech E. It is time for enhanced recovery after surgery in cardiac surgery. Kardiol Pol. 2017;75(5):415-420. doi: 10.5603/KP.a2017.0014. Epub 2017 Feb 2. No abstract available.

  PMID: 28150277 BACKGROUND

• Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.

  PMID: 9175983 BACKGROUND

• Coleman SR, Chen M, Patel S, Yan H, Kaye AD, Zebrower M, Gayle JA, Liu H, Urman RD. Enhanced Recovery Pathways for Cardiac Surgery. Curr Pain Headache Rep. 2019 Mar 14;23(4):28. doi: 10.1007/s11916-019-0764-2.

  PMID: 30868281 BACKGROUND

• Zaouter C, Imbault J, Labrousse L, Abdelmoumen Y, Coiffic A, Colonna G, Jansens JL, Ouattara A. Association of Robotic Totally Endoscopic Coronary Artery Bypass Graft Surgery Associated With a Preliminary Cardiac Enhanced Recovery After Surgery Program: A Retrospective Analysis. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1489-97. doi: 10.1053/j.jvca.2015.03.003. Epub 2015 Mar 5.

  PMID: 26119408 BACKGROUND

• Fleming IO, Garratt C, Guha R, Desai J, Chaubey S, Wang Y, Leonard S, Kunst G. Aggregation of Marginal Gains in Cardiac Surgery: Feasibility of a Perioperative Care Bundle for Enhanced Recovery in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):665-70. doi: 10.1053/j.jvca.2016.01.017. Epub 2016 Jan 16.

  PMID: 27321791 BACKGROUND

• Williams JB, McConnell G, Allender JE, Woltz P, Kane K, Smith PK, Engelman DT, Bradford WT. One-year results from the first US-based enhanced recovery after cardiac surgery (ERAS Cardiac) program. J Thorac Cardiovasc Surg. 2019 May;157(5):1881-1888. doi: 10.1016/j.jtcvs.2018.10.164. Epub 2018 Dec 8.

  PMID: 30665758 BACKGROUND

• Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.

  PMID: 31054241 BACKGROUND

• Pokhrel S, Gregory A, Mellor A. Perioperative care in cardiac surgery. BJA Educ. 2021 Oct;21(10):396-402. doi: 10.1016/j.bjae.2021.05.008. Epub 2021 Jul 13. No abstract available.

  PMID: 34567795 BACKGROUND

• Cohen B, Turan A. Enhanced recovery after cardiac surgery - Is evidence still necessary? J Clin Anesth. 2019 May;54:171-172. doi: 10.1016/j.jclinane.2018.12.049. Epub 2018 Dec 29. No abstract available.

  PMID: 30599274 BACKGROUND

• Noss C, Prusinkiewicz C, Nelson G, Patel PA, Augoustides JG, Gregory AJ. Enhanced Recovery for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2760-2770. doi: 10.1053/j.jvca.2018.01.045. Epub 2018 Jan 31.

  PMID: 29503121 BACKGROUND

• Bianchi P, Constantine A, Costola G, Mele S, Shore D, Dimopoulos K, Aw TC. Ultra-Fast-Track Extubation in Adult Congenital Heart Surgery. J Am Heart Assoc. 2021 Jun;10(11):e020201. doi: 10.1161/JAHA.120.020201. Epub 2021 May 17.

  PMID: 33998289 BACKGROUND

• Zayat R, Menon AK, Goetzenich A, Schaelte G, Autschbach R, Stoppe C, Simon TP, Tewarie L, Moza A. Benefits of ultra-fast-track anesthesia in left ventricular assist device implantation: a retrospective, propensity score matched cohort study of a four-year single center experience. J Cardiothorac Surg. 2017 Feb 8;12(1):10. doi: 10.1186/s13019-017-0573-9.

  PMID: 28179009 BACKGROUND

• Xu J, Zhou G, Li Y, Li N. Benefits of ultra-fast-track anesthesia for children with congenital heart disease undergoing cardiac surgery. BMC Pediatr. 2019 Dec 11;19(1):487. doi: 10.1186/s12887-019-1832-9.

  PMID: 31829170 BACKGROUND

• Akhtar MI, Momeni M, Szekely A, Hamid M, El Tahan MR, Rex S. Multicenter International Survey on the Clinical Practice of Ultra-Fast-Track Anesthesia with On-Table Extubation in Pediatric Congenital Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):406-415. doi: 10.1053/j.jvca.2018.07.006. Epub 2018 Jul 7.

  PMID: 30115517 BACKGROUND

• Jiang S, Wang L, Teng H, Lou X, Wei H, Yan M. The Clinical Application of Ultra-Fast-Track Cardiac Anesthesia in Right-Thoracoscopic Minimally Invasive Cardiac Surgery: A Retrospective Observational Study. J Cardiothorac Vasc Anesth. 2023 May;37(5):700-706. doi: 10.1053/j.jvca.2023.01.010. Epub 2023 Jan 13.

  PMID: 36804223 BACKGROUND

• Ahmad U, Khattab MA, Schaelte G, Goetzenich A, Foldenauer AC, Moza A, Tewarie L, Stoppe C, Autschbach R, Schnoering H, Zayat R. Combining Minimally Invasive Surgery With Ultra-Fast-Track Anesthesia in HeartMate 3 Patients: A Pilot Study. Circ Heart Fail. 2022 May;15(5):e008358. doi: 10.1161/CIRCHEARTFAILURE.121.008358. Epub 2022 Mar 7.

  PMID: 35249368 BACKGROUND

• Feng J, Wang H, Peng L, Xu H, Song X. Effects of Thoracic Paravertebral Block on Postoperative Analgesia in Infants and Small Children undergoing Ultra-Fast Track Cardiac Anesthesia: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2023 Apr;37(4):539-546. doi: 10.1053/j.jvca.2022.12.006. Epub 2022 Dec 11.

  PMID: 36717316 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mei J Yan, QC

  Zhejiang Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Mei J Yan, QC

CONTACT

+863313957116714; 1514018695@qq.com

Han W Wei, secretary

CONTACT

+863317816112656; wzero1017@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 7, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share