Evaluation of the Safety and Rapid Recovery Effect of the Tubeless Strategy in Lung Transplantation: a Prospective, Multicenter, Partially Double-blind, Randomized Controlled Clinical Study (Tubeless-LTx-2)

Guangzhou Medical University

Status: Not yet enrolling

Conditions: Lung Transplant Recipient

Treatments: Procedure: Tubeless Lung Transplantation Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07120230

Tubeless-LTx-2025 (Registry Identifier)

Details and patient eligibility

About

Study Summary This study aimed to systematically evaluate the clinical value of a tubeless spontaneous breathing anesthesia strategy in lung transplantation, focusing on its comprehensive effectiveness in controlling early postoperative complications, promoting rapid recovery, and ensuring safety. The study design was a prospective, multicenter, partially double-blind, randomized controlled clinical trial comparing short-term clinical outcomes between tubeless lung transplantation and lung transplantation with conventional general anesthesia using endotracheal intubation.

The primary endpoint was the overall incidence of early complications within 30 days after surgery.

Secondary endpoints included intraoperative parameters (such as anesthesia recovery time, laryngeal mask/endotracheal tube removal rate, operative time, oxygenation/ventilation indicators, and anesthetic medication use), postoperative recovery indicators (such as ICU and total hospital stay length of stay, postoperative sedation/analgesia/antimicrobial use, and hospitalization costs), and 90-day survival and cause of death analysis.

This study employed a partially double-blind design: participants, outcome assessors, data management personnel, and statistical analysts remained blinded to the procedure. The study design was a 1:1 randomized, partially double-blind, controlled, multicenter trial. All subjects were randomly assigned to the Tubeless group (experimental group) or the endotracheal intubation group (control group) after completing preoperative evaluation and informed consent, and received standardized surgery and perioperative management.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects must voluntarily participate in this study, possess full civil capacity, be able to understand the study protocol, and sign a written informed consent.
2. Be between 18 and 74 years of age.
3. 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.
4. Have an American Society of Anesthesiologists (ASA) anesthesia grade 4 or lower and be expected to be able to tolerate anesthesia.
5. 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 venovenous extracorporeal membrane oxygenation (ECMO) support 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).

Exclusion criteria

1. Refusing to sign informed consent or withdrawing informed consent during the trial;
2. Planning to undergo a second lung transplant or a combined multi-organ transplant (such as heart-lung, lung-liver, lung-kidney, etc.);
3. Clearly combined with uncontrollable active infection (such as tuberculosis, uncontrolled fungal infection) or sepsis;
4. Patients with obvious neuropsychiatric disorders, unconsciousness or long-term use of sedative/analgesic psychotropic drugs before surgery;
5. Active malignant tumors (except those treated within the past 2 years) or those with a high risk of postoperative recurrence;
6. Clearly diagnosed severe chest deformity or spinal deformity that may affect lung compliance during surgery;
7. Serum anti-HLA high sensitization (PRA ≥ 80%) and no matching donor available;
8. There are clear contraindications to the planned tubeless surgical anesthesia strategy (such as expected intraoperative airway difficulty, pharyngeal stenosis and laryngeal mask unsuitable, etc.);
9. BMI ≥ 30 kg/m² or < 16 kg/m². 10) Pregnant or lactating women.

11. Other conditions deemed unsuitable for participation in this study by the investigator (e.g., anticipated inability to complete follow-up, concurrent malignancy, etc.).

12. Patients with bronchiectasis or bronchial vascular hyperplasia difficult to manage with interventional therapy prior to surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Tubeless LTx Group

Experimental group

Description:

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.

Treatment:

Procedure: Tubeless Lung Transplantation Surgery

Traditional LTx Group

Sham Comparator group

Description:

Participants in this group will undergo standard lung transplantation surgery with invasive mechanical ventilation using a double-lumen endotracheal tube. General anesthesia is maintained with intravenous medications (propofol, remifentanil, and dexmedetomidine) and muscle relaxants. Lung ventilation during surgery is precisely controlled by a ventilator. After surgery, the endotracheal tube will remain in place until the patient's condition allows safe removal. Participants may be supported by mechanical ventilation or extracorporeal membrane oxygenation (ECMO) postoperatively, if necessary, and will be transferred to the ICU for continued monitoring and care.

Treatment:

Procedure: Tubeless Lung Transplantation Surgery