Tubeless Strategy in Lung Transplantation: A Prospective Single-Arm Study (NCT07120230) | Clinical Trial Compass
CompletedNot Applicable
Tubeless Strategy in Lung Transplantation: A Prospective Single-Arm Study
China30 participantsStarted 2025-08-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom from invasive ventilation in the operating room
Timeframe: From end of surgery (postoperative day 0) through 72 hours postoperatively (up to 72 hours).
Trial details
NCT IDNCT07120230
SponsorThe First Affiliated Hospital of Guangzhou Medical University
. 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.);