[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622511":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":20,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":54,"whyStopped":20,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":20},{"fullName":5,"class":6},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tubeless LTx Group","EXPERIMENTAL","All participants receive lung transplantation under a standardized spontaneous-breathing-preserving (\"tubeless\") pathway. After anesthesia induction, a supraglottic airway (laryngeal mask airway) is used when feasible with regional nerve blocks and multimodal sedation\u002Fanalgesia to control pain and cough while maintaining spontaneous breathing. Muscle relaxants are minimized; ventilatory assistance is provided only as needed with low airway pressures. Postoperatively, patients are managed in the intensive care unit with spontaneous breathing and protocol-guided noninvasive respiratory support. Conversion to endotracheal intubation, invasive mechanical ventilation, and\u002For extracorporeal membrane oxygenation is allowed if predefined safety criteria are met.",[13],"Procedure: Lung transplantation that preserves spontaneous breathing function",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Lung transplantation that preserves spontaneous breathing function","This intervention uses a spontaneous-breathing-preserving anesthesia strategy during lung transplantation, which differs from conventional management based on endotracheal intubation and invasive mechanical ventilation. A supraglottic airway (laryngeal mask airway) is used when feasible instead of endotracheal intubation to maintain spontaneous breathing throughout the procedure. Neuromuscular blocking agents are minimized, and regional nerve blocks (such as intercostal nerve blocks or paravertebral blocks) are used to control pain and suppress cough while preserving the patient's ability to breathe independently. After surgery, patients receive protocol-guided noninvasive respiratory support (for example, high-flow nasal oxygen or noninvasive ventilation), with the goal of avoiding routine invasive mechanical ventilation.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jiaqin Zhang, M.D.","CONTACT","+8613662833144","zhang_jqwow@163.com",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Jianxing He","Chief Physician and Professor of Thoracic Surgery","100622511","perioperative-recovery-outcomes-with-a-spontaneous-breathing-strategy-in-severely-underweight-lung-transplant-recipients-100622511",false,"NCT07384572","Perioperative Recovery Outcomes With a Spontaneous Breathing Strategy in Severely Underweight Lung Transplant Recipients","Evaluation of Perioperative Recovery Outcomes of a Spontaneous Breathing-Preserving Strategy in Severely Underweight Lung Transplantation: A Prospective, Multicenter, Single-Arm Clinical Study","\\[1\\] Inclusion Criteria\n\n1. Age and informed consent: Age ≥18 years; able to understand the study and provide written informed consent; willing and able to comply with follow-up.\n2. Transplant candidacy: Listed in CLuTR or the participating center's lung transplant waiting list and scheduled to undergo allogeneic lung transplantation.\n3. Low body weight definition (core cohort criterion): Preoperative BMI \\\u003C16 kg\u002Fm², calculated using the most recent traceable preoperative height and weight within the evaluation window.\n4. Preoperative support status: Not receiving ongoing invasive mechanical ventilation (endotracheal intubation or tracheostomy) and not on ECMO or other extracorporeal life support preoperatively.\n5. Minimum acceptable end-organ function: LVEF ≥40%; eGFR ≥40 mL\u002Fmin\u002F1.73 m²; no evidence of acute liver failure or decompensated cirrhosis\u002Fportal hypertension; American Society of Anesthesiologists (ASA) physical status ≤ IV.\n6. Infection and transmissible diseases: No evidence of active infection; no active tuberculosis; HIV\u002FHBV\u002FHCV status meeting center transplant requirements (e.g., undetectable viral load, where applicable).\n7. Rehabilitation and support: Demonstrated potential for postoperative rehabilitation (able to participate in training) and reliable caregiving support (at least one primary caregiver).\n\n\\[2\\] Exclusion Criteria\n\n1. Consent\u002Fcompliance: Refusal or withdrawal of informed consent; investigator judgment that follow-up cannot be completed or presence of recurrent severe non-adherence.\n2. Transplant type: Retransplantation, multi-organ transplantation, or planned lobar lung transplantation.\n3. Recent major cardiovascular\u002Fcerebrovascular events: Acute coronary syndrome\u002Fmyocardial infarction or stroke within the past 30 days.\n4. Severe organ dysfunction\u002Facute failure: LVEF \\\u003C40%; eGFR \\\u003C40 mL\u002Fmin\u002F1.73 m²; acute liver failure or decompensated cirrhosis\u002Fportal hypertension; acute renal failure requiring dialysis with low likelihood of recovery; significant preoperative neuropsychiatric disorder or altered mental status.\n5. High-risk\u002Fsevere infection: Septic shock; active extrapulmonary or disseminated infection; active tuberculosis; detectable HIV viral load (or otherwise not meeting center transplant standards).\n6. High bleeding risk: Severe bronchiectasis not treated with preoperative vascular intervention or not readily correctable.\n7. Malignancy: Active malignancy or malignancy with high risk of recurrence or cancer-related mortality.\n8. Severe chest wall or spinal deformity: Definitively diagnosed severe thoracic cage deformity or spinal deformity.\n9. Substance use\u002Fdependence: Current use of cigarettes, e-cigarettes, inhaled cannabis, or intravenous drugs.\n10. Tubeless\u002Fspontaneous breathing-preserving strategy not safely feasible: Determined by the anesthesia team to have a difficult airway or unsafe supraglottic\u002Fnon-intubated airway management (e.g., anticipated intraoperative airway difficulty, pharyngeal\u002Flaryngeal narrowing not suitable for a laryngeal mask airway), including but not limited to: Mallampati class \\>III, mouth opening \\\u003C3 cm, thyromental distance \\\u003C5 cm, or significant airway anatomic variants (e.g., aberrant right upper lobe bronchial takeoff in a planned right lung transplant) deemed difficult to manage safely with an LMA or single-lumen tube.\n11. Donor\u002Fdonor lung limitations: Donor age \\>60 years; donor mechanical ventilation \\>14 days; positive donor airway microbiology deemed unacceptable by the transplant team.\n12. Protected populations: Pregnant or breastfeeding women.","ALL","18 Years","74 Years",{"count":42,"type":43},56,"ESTIMATED","INTERVENTIONAL",[46],"NA","The goal of this prospective, multicenter, single-arm clinical study is to learn whether a spontaneous breathing-preserving perioperative management strategy can improve recovery and is safe in lung transplant recipients with very low body weight (body mass index \\[BMI\\] \\\u003C16 kg\u002Fm²).\n\nThe main questions it aims to answer are whether, in lung transplant recipients with very low body weight (BMI \\\u003C16 kg\u002Fm²), a spontaneous breathing-preserving anesthesia-surgical strategy combined with standardized nutritional optimization and a prehabilitation program can improve early postoperative recovery and perioperative survival. Specifically, the study will assess the proportion of participants who require postoperative invasive mechanical ventilation, postoperative length of hospital stay, and perioperative survival within the protocol-defined time window (e.g., through hospital discharge).\n\nParticipants will undergo lung transplantation using a perioperative strategy that preserves spontaneous breathing whenever clinically appropriate, with predefined criteria for conversion to endotracheal intubation and mechanical ventilation if needed. They will receive standard postoperative monitoring and supportive care, with respiratory support events and perioperative complications assessed during the index hospitalization (and up to 30 days after surgery, if specified in the protocol). Key outcomes will be collected from routine clinical care, including postoperative ventilatory support status, length of hospital stay, and major safety events.",[49],"End-stage Lung Disease",[51,52,53],"Lung transplantation","Enhanced Recovery After Surgery","Severely Underweight","NOT_YET_RECRUITING","2026-01-31",{"date":57,"type":58},"2026-02-03","ACTUAL",{"date":60,"type":43},"2026-01-13",{"date":62,"type":43},"2029-01-30",{"name":5,"class":6}]