Evaluation of the Safety and Rapid Recovery Effect of the Tubeless Strategy in Lung Transplantation: A Prospective Single-Arm Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Freedom from invasive ventilation in the operating room
研究概览
简要总结
This prospective, single-center, single-arm study evaluates the feasibility, safety, and rapid recovery outcomes of a tubeless strategy in lung transplantation. Consecutive eligible adult lung transplant recipients undergo lung transplantation without standard endotracheal intubation, using a laryngeal mask airway and standardized regional anesthesia and intravenous sedation protocols.
The primary outcome is freedom from invasive ventilation in the operating room, defined as removal of the airway device before leaving the operating room with no reinstitution of invasive ventilation within 72 hours. Secondary outcomes include postoperative ICU length of stay, postoperative hospital length of stay, postoperative invasive ventilation requirement, postoperative complications (assessed up to 30 days), and perioperative mortality.
详细描述
The study was initially registered as a randomized controlled trial. However, randomization was not feasible due to patient refusal of treatment allocation. Therefore, the study proceeded as a prospective single-arm cohort with consecutive enrollment. Outcome definitions remained unchanged. The study was conducted at a single center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Outcomes Assessor)
盲法说明
Outcomes were assessed using predefined criteria; where feasible, assessors performing outcome adjudication were not involved in perioperative airway management.
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must voluntarily participate in this study, possess full civil capacity, be able to understand the study protocol, and sign a written informed consent.
- •Be between 18 and 74 years of age.
- •Be listed on the lung transplant waiting list of the China Lung Transplant Registry (CLuTR) or their respective centers and intend to undergo lung transplantation.
- •Have an American Society of Anesthesiologists (ASA) anesthesia grade 4 or lower and be expected to be able to tolerate anesthesia.
- •Preoperative assessment indicates that cardiac function (LVEF ≥ 50%), renal function (eGFR ≥ 60 mL/min/1.73 m²), and liver function (Child-Pugh A) are compatible with surgery. 6) Completed the pre-lung transplant respiratory rehabilitation program assessment and demonstrated good compliance;
- •7) Not receiving continuous endotracheal intubation or tracheostomy prior to surgery; 8) No active infection, including active tuberculosis, HIV, or positive hepatitis B/C viral load before surgery; 9) Have a clear and reliable post-operative care support system (including at least one primary caregiver).
排除标准
- •Refusing to sign informed consent or withdrawing informed consent during the trial;
- •Planning to undergo a second lung transplant or a combined multi-organ transplant (such as heart-lung, lung-liver, lung-kidney, etc.);
- •Clearly combined with uncontrollable active infection (such as tuberculosis, uncontrolled fungal infection) or sepsis;
- •Patients with obvious neuropsychiatric disorders, unconsciousness or long-term use of sedative/analgesic psychotropic drugs before surgery;
- •Active malignant tumors (except those treated within the past 2 years) or those with a high risk of postoperative recurrence;
- •Clearly diagnosed severe chest deformity or spinal deformity that may affect lung compliance during surgery;
- •Serum anti-HLA high sensitization (PRA ≥ 80%) and no matching donor available;
- •There are clear contraindications to the planned tubeless surgical anesthesia strategy (such as expected intraoperative airway difficulty, pharyngeal stenosis and laryngeal mask unsuitable, etc.);
- •Pregnant or lactating women.
- •Other conditions deemed unsuitable for participation in this study by the investigator (e.g., anticipated inability to complete follow-up, concurrent malignancy, etc.).
- •Patients with bronchiectasis or bronchial vascular hyperplasia difficult to manage with interventional therapy prior to surgery.
研究组 & 干预措施
Tubeless LTx Group
Participants in this group will receive lung transplantation surgery without standard tracheal intubation. Instead, they will breathe on their own using a special airway device called a laryngeal mask airway (LMA), combined with a bronchial blocker to separate lung ventilation during surgery. Sedation is maintained with intravenous medications (propofol, remifentanil, and dexmedetomidine), and participants will remain spontaneously breathing or receive minimal breathing assistance as needed. The surgical incision will be numbed using local anesthesia with lidocaine and ropivacaine injections. After surgery, the LMA will be removed in the operating room, and participants will transition directly to non-invasive breathing support before being monitored in the ICU.
干预措施: Tubeless Lung Transplantation Surgery (Procedure)
结局指标
主要结局
Freedom from invasive ventilation in the operating room
时间窗: From end of surgery (postoperative day 0) through 72 hours postoperatively (up to 72 hours).
Proportion of participants who have the airway device removed before leaving the operating room and do not require reinstitution of invasive ventilation within 72 hours after surgery.
次要结局
未报告次要终点
研究者
Jianxing He
Dean, Professor
The First Affiliated Hospital of Guangzhou Medical University