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

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

Interventions

PROCEDURE

Ultra-Fast-Track Cardiac Anesthesia(UFTCA)

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

PROCEDURE

conventional general anesthesia (CGA)

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

Sponsors & Collaborators

• Beijing Anzhen Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Wuhan Asia Heart Hospital

  collaborator OTHER

• Tianjin Chest Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  lead OTHER

Principal Investigators

• Mei J Yan, QC · Zhejiang Provincial People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-31

Primary Completion

2028-12-31

Completion

2028-12-31