Lung Transplant RecipientTubeless-LTx-2NCT07120230
Tubeless Strategy in Lung Transplantation: A Prospective Single-Arm Study
A study testing Tubeless Lung Transplantation Surgery in people with Lung Transplant Recipient, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Lung Transplant Recipient
- What is being tested?
- Tubeless Lung Transplantation Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510163
About this study
Official title: Evaluation of the Safety and Rapid Recovery Effect of the Tubeless Strategy in Lung Transplantation: A Prospective Single-Arm Clinical Study
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.
Read the detailed description
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.
- Conditions
- Lung Transplant Recipient
- Being tested
- Tubeless Lung Transplantation Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubeless Lung Transplantation SurgeryProcedure or surgery
Patients undergoing this surgery 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.
| Study group | Role | What they receive |
|---|---|---|
| Tubeless LTx Group | Experimental | 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. Receives: Procedure: Tubeless Lung Transplantation Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from invasive ventilation in the operating room
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.
Measured: From end of surgery (postoperative day 0) through 72 hours postoperatively (up to 72 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start3 Aug 2025
- Primary completion30 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RecipientStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120230
- Sponsor's protocol ID
- Tubeless-LTx-2025
- Other IDs
- Tubeless-LTx-2025
- Acronym
- Tubeless-LTx-2
- Status last verified
- Feb 2026
- First submitted
- 6 Aug 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Rapid Recovery Effect of the Tubeless Strategy in Lung Transplantation: A Prospective Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07120230
- Acronym / sponsor ID
- Tubeless-LTx-2 / Tubeless-LTx-2025
- Conditions
- Lung Transplant Recipient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 3 Aug 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tubeless LTx Group | Experimental | Procedure: Tubeless Lung Transplantation SurgeryParticipants 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tubeless Lung Transplantation SurgeryPatients undergoing this surgery 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. | Procedure or surgery | Tubeless LTx Group |
Primary outcome
Freedom from invasive ventilation in the operating room
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubeless Lung Transplantation Surgery in people with Lung Transplant Recipient, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from invasive ventilation in the operating room (time frame: From end of surgery (postoperative day 0) through 72 hours postoperatively (up to 72 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.