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Clinical application of Tubeless in minimally invasive thoracic surgery:a prospective randomized controlled trial

Clinical application of Tubeless in minimally invasive thoracic surgery:a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101459
Enrollment
Unknown
Registered
2025-04-25
Start date
2025-05-06
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary diseases and Mediastinal diseases

Interventions

Tubeless group:The patient underwent minimally invasive thoracic surgery with "tubeless" approach. During the operation, anesthesia was administered without endotracheal intubation. After the surgery,
Control group:The patient underwent conventional minimally invasive thoracic surgery. During the operation, general anesthesia with tracheal intubation was adopted. After the operation, a closed thora

Sponsors

The Affliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Intended to undergo minimally invasive thoracic surgery; 2. Age 18-20 years old, gender unrestricted; 3. American Society of Anesthesiologists (ASA) score of I-III; 4. Body Mass Index (BMI) = 1.5 x 109/L, platelets >= 100 x 109/L, hemoglobin >= 9 g/dL; • Liver function: Total bilirubin = 45 mL/min (Cockcroft-Gault formula); • Coagulation function: International Normalized Ratio (INR) or prothrombin time (PT) <= 1.5 times the upper limit of normal (ULN); 7. Able to understand and cooperate with the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patient-related factors: a. Patients who refuse surgery and/or the anesthesia plan; b. Patients with any severe or uncontrollable systemic diseases, such as: 1) Major and symptomatic severe arrhythmias, conduction abnormalities or morphological abnormalities on resting electrocardiogram that are difficult to control, such as second-degree or higher atrioventricular block, ventricular arrhythmias or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification > grade 2; 3) Any arterial thrombosis, embolism or ischemia within 6 months before enrollment in the treatment, such as myocardial infarction, cerebrovascular accident or transient ischemic attack, etc.; 4) History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or current clinical active interstitial lung disease; 5) Active pulmonary tuberculosis; 6) Active or uncontrolled infection requiring systemic treatment; 7) Active diverticulitis, abdominal abscess, gastrointestinal obstruction; 8) Liver diseases such as liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 9) Urine routine test showing urine protein >++, and confirmed 24-hour urine protein quantification > 1.0 g; 10) Patients with mental disorders and inability to cooperate with treatment; c. Relative contraindications: upper airway secretions or persistent cough; d. History of ipsilateral surgery and other conditions that may cause extensive pleural adhesions; e. Diaphragmatic nerve palsy on the non-surgical side; f. History or evidence of disease, treatment or abnormal laboratory test values that may interfere with the trial results or prevent the subject from fully participating in the study, or other situations deemed unsuitable for inclusion by the investigator. The investigator deems there are other potential risks that make the subject unsuitable for participation in this study. 2. Surgery-related factors: a. Extensive pleural adhesions; b. Previous ipsilateral lung surgery history; c. Preoperative pleural effusion; emphysematous lung, residual bullae.

Design outcomes

Primary

MeasureTime frame
Postoperative pulmonary complications, PPCS;quality of recovery-15 scale (QoR-15);

Secondary

MeasureTime frame
Postoperative ambulation time;postoperative length of stay;PO2, PCO2;Visual Analogue Scale (VAS) score;conversion rate;the percentage of neutrophilic granulocyte,CRP,IL-6,TNF,IFN;Nausea;Vomiting;Voice hoarseness;Sore throat;

Countries

China

Contacts

Public ContactJiao Wenjie

The Affliated Hospital of Qingdao University

Jiaowenjie@163.com+86 186 6180 6899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026