An interventional study of non-intubated tracheal and carinal reconstruction and intubated tracheal and carinal reconstruction in Tracheal Disease and Airway Disease, sponsored by Shuben Li. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Shuben Li · Not applicable, Interventional, and Treatment
In recent year, non-intubated anesthesia had emerged as an available alternative for thoracic procedure. Whether non-intubated tracheal/carinal reconstruction confers distinct perioperative advantages over the conventional intubated approach remains uncertain. The purpose of this study was to evaluate the safety and perioperative outcomes of non-intubated versus intubated approaches in tracheal and carinal reconstruction.
Tracheal/carinal resection and reconstruction remains a technically demanding procedure with high risks of morbidity and mortality. Traditionally, tracheal surgery is performed under intubated anesthesia, with intermittent endotracheal ventilation to maintain oxygenation during airway reconstruction. However, endotracheal intubation with cross-field ventilation obstructs the surgical field and potentially complicating the reconstruction procedure. Non-intubated anesthesia have has gained widespread adoption for modern thoracic surgery. However, the safety and feasibility of non-intubated tracheal and carinal reconstruction have not been studied by randomized controlled trial. So, this randomized controlled trial aims to evaluate whether the non-intubated approach offers comparable short-term and long-term outcomes to the conventional intubated procedure.
33 studies on the registry are indexed under Tracheal Diseases; 7 are open to participants now.
This study's planned enrollment of 176 is above the median of 34 across 22 interventional studies indexed under Tracheal Diseases.
Browse Tracheal Diseases studies →Shuben Li is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical procedure: non-intubated tracheal and carinal reconstruction
Procedure: non-intubated tracheal and carinal reconstruction
Surgical procedure: intubated tracheal and carinal reconstruction
Procedure: intubated tracheal and carinal reconstruction
non-intubated tracheal and carinal reconstruction
intubated tracheal and carinal reconstruction
Conversion rate
The rate of conversion to intubated approach in the operation
Time frame: postoperative in-hospital stay up to 30 days
Postoperative complications rate
Number and severity of adverse events that are related to the treatment of each patient. Postoperative treatment-related complications were assessed by the Clavien-Dindo Classification. Treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: postoperative in-hospital stay up to 30 days
Operative time
Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin).
Time frame: postoperative in-hospital stay up to 30 days
Length of stay (LOS)
Length of stay is the duration for enrolled patients until the date of meeting the criteria of hospital discharge since the date of surgery.
Time frame: postoperative in-hospital stay up to 30 days
Postoperative ICU stay
Postoperative hospital stay is the duration for each patients until the date of meeting the criteria of ICU discharge since the date of surgery.
Time frame: postoperative in-hospital stay up to 30 days
Intraoperative bleeding loss
blood loss in the operation
Time frame: postoperative in-hospital stay up to 30 days
Length of resection
Length of resection in the operation
Time frame: postoperative in-hospital stay up to 30 days
Reconstruction time
Reconstruction time was defined as the time between the start of resection (tracheal) and the finish of reconstruction (tracheal).
Time frame: postoperative in-hospital stay up to 30 days
Volume of postoperative drainage
The volume of postoperative drainage of the patient was the sum of his daily drainage volume after the surgery.
Time frame: postoperative in-hospital stay up to 30 days
1-year disease-free survival (DFS)
DFS at 1 year after surgery
Time frame: 1 year after surgery
1-year overall survival(OS)
OS after surgery
Time frame: 1 year after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for May 2028, 37 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Shuben Li