Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07065565

Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction

Led by Shuben Li · Updated on 2025-07-15

176

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and outcomes of two anesthesia approaches for tracheal and carinal reconstruction in patients with airway or tracheal diseases. This trial compares the traditional intubated anesthesia method, which uses endotracheal ventilation but can obstruct the surgical field, with a newer non-intubated anesthesia technique that may offer advantages during surgery. The study aims to determine if the non-intubated approach has similar or better short-term and long-term results compared to the conventional method. Participants will be randomly assigned to one of two groups: one receiving non-intubated tracheal and carinal reconstruction, and the other receiving the standard intubated procedure. Both groups undergo the surgical reconstruction, but the anesthesia delivery differs. The trial does not use masking or blinding, and the procedures are performed under medical supervision to assess their comparative effects on perioperative outcomes. During the study, researchers will monitor participants closely for outcomes such as conversion rates, postoperative complications, operative time, length of hospital and ICU stays, blood loss, reconstruction time, and drainage volume during the hospital stay up to 30 days after surgery. They will also track disease-free and overall survival rates for one year post-surgery. Participants will receive all necessary evaluations and care throughout the study period to ensure safety and accurate data collection.

CONDITIONS

Brief Title

Tubeless Tracheal and Carinal Reconstruction

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Airway diseases diagnosed by chest enhanced CT and bronchoscopy
  • Age between 18 and 80 years old
  • ASA (American Society of Anesthesiologists) stage I to III
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • History of congestive heart failure, angina without good control, ECG-proved myocardial infarction, uncontrolled hypertension, significant valvulopathy, or high-risk arrhythmia
  • Severe systemic diseases such as active infection, poorly controlled diabetes, coagulation disorders, hemorrhagic tendency, or current thrombolysis/anticoagulant therapy
  • Airway anatomical abnormalities due to previous surgery
  • Presence of other malignancies

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Postoperative in-hospital stay up to 30 days

Participants undergo either non-intubated or intubated tracheal and carinal reconstruction surgery and receive immediate post-operative care during their hospital stay.

Continuous monitoring during hospital stay

Post-operative Follow-up

Duration - Up to 1 year after surgery

Participants are followed for their recovery and survival outcomes after surgery.

Follow-up visits as scheduled up to 1 year

Trial Site Locations

Total: 1 location

1

the First Affiliated Hospital of Guangzhou Medical University

Guangdong, Gaungzhou, China, 510120

Actively Recruiting

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Research Team

S

Shuben Li

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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