Tracheal DiseaseNOVA-01NCT07065565
Tubeless Tracheal and Carinal Reconstruction
A study testing non-intubated tracheal and carinal reconstruction and intubated tracheal and carinal reconstruction in people with Tracheal Disease and Airway Disease, run by Shuben Li at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheal Disease, Airway Disease
- What is being tested?
- non-intubated tracheal and carinal reconstruction and intubated tracheal and carinal reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Airway diseases were diagnosed by chest enhanced CT and bronchoscopy
- The patients with age ≥ 18 and ≤ 80 years old
- ASA (American Society of Anesthesiologists) stage: I-III
- sign the informed consent. -
Who cannot join
- The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control
- The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy
- Airway anatomical abnormalities due to a history of surgery
- Patients present with other malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Guangzhou Medical University
Guangdong, Gaungzhou, 510120
About this study
Official title: Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction
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.
Read the detailed description
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.
- Conditions
- Tracheal Disease, Airway Disease
- Being tested
- non-intubated tracheal and carinal reconstruction, intubated tracheal and carinal reconstruction
- Keywords
- non-intubated anesthesia, airway disease, tracheal reconstruction, carinal reconstruction
- Medical subject headings
- Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-intubated tracheal and carinal reconstructionProcedure or surgery
non-intubated tracheal and carinal reconstruction
intubated tracheal and carinal reconstructionProcedure or surgery
intubated tracheal and carinal reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Non-intubated group | Experimental | Surgical procedure: non-intubated tracheal and carinal reconstruction Receives: Procedure: non-intubated tracheal and carinal reconstruction |
| Intubated group | Active comparator | Surgical procedure: intubated tracheal and carinal reconstruction Receives: Procedure: intubated tracheal and carinal reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
The rate of conversion to intubated approach in the operation
Measured: 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.
Measured: postoperative in-hospital stay up to 30 days
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: postoperative in-hospital stay up to 30 days
Intraoperative bleeding loss
blood loss in the operation
Measured: postoperative in-hospital stay up to 30 days
Length of resection
Length of resection in the operation
Measured: 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).
Measured: 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.
Measured: postoperative in-hospital stay up to 30 days
1-year disease-free survival (DFS)
DFS at 1 year after surgery
Measured: 1 year after surgery
1-year overall survival(OS)
OS after surgery
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start26 Mar 2025
- Primary completion1 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuben Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuben Li, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065565
- Sponsor's protocol ID
- ES-2025-075-01
- Acronym
- NOVA-01
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jul 2025
- 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 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction
- ClinicalTrials.gov ID
- NCT07065565
- Acronym / sponsor ID
- NOVA-01 / ES-2025-075-01
- Conditions
- Tracheal Disease, Airway Disease
- Keywords
- non-intubated anesthesia, airway disease, tracheal reconstruction, carinal reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Shuben LiUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 15 Jul 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-intubated group | Experimental | Procedure: non-intubated tracheal and carinal reconstructionSurgical procedure: non-intubated tracheal and carinal reconstruction |
| Intubated group | Active comparator | Procedure: intubated tracheal and carinal reconstructionSurgical procedure: intubated tracheal and carinal reconstruction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Airway diseases were diagnosed by chest enhanced CT and bronchoscopy
- The patients with age ≥ 18 and ≤ 80 years old
- ASA (American Society of Anesthesiologists) stage: I-III
- sign the informed consent. -
Key exclusion criteria (4 listed)
- The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control
- The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy
- Airway anatomical abnormalities due to a history of surgery
- Patients present with other malignancy
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 |
|---|---|---|
| non-intubated tracheal and carinal reconstructionnon-intubated tracheal and carinal reconstruction | Procedure or surgery | Non-intubated group |
| intubated tracheal and carinal reconstructionintubated tracheal and carinal reconstruction | Procedure or surgery | Intubated group |
Primary outcome
Conversion rate
Time frame: postoperative in-hospital stay up to 30 days
The rate of conversion to intubated approach in the operation
Postoperative complications rate
Time frame: postoperative in-hospital stay up to 30 days
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.
9 secondary outcomes
Operative time
Time frame: postoperative in-hospital stay up to 30 days
Length of stay (LOS)
Time frame: postoperative in-hospital stay up to 30 days
Postoperative ICU stay
Time frame: postoperative in-hospital stay up to 30 days
Intraoperative bleeding loss
Time frame: postoperative in-hospital stay up to 30 days
Length of resection
Time frame: postoperative in-hospital stay up to 30 days
Reconstruction time
Time frame: postoperative in-hospital stay up to 30 days
Volume of postoperative drainage
Time frame: postoperative in-hospital stay up to 30 days
1-year disease-free survival (DFS)
Time frame: 1 year after surgery
1-year overall survival(OS)
Time frame: 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-intubated tracheal and carinal reconstruction and intubated tracheal and carinal reconstruction in people with Tracheal Disease and Airway Disease, run by Shuben Li 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuben Li (86+(020) 8306 2114, 13500030280@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: postoperative in-hospital stay up to 30 days). The study lists 2 primary outcomes in all. 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 15 Jul 2025.