Tubeless Strategy in Lung Transplantation: A Prospective Single-Arm Study

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.

Inclusion criteria

• 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;

• 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).

Exclusion criteria

• 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.