NCT06848751 Tubeless Surgery With Impaired Pulmonary Function
| NCT ID | NCT06848751 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Second Hospital of Shandong University |
| Condition | Lung Function Decreased |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2021-04-10 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2021-04-10 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Some patients with impaired lung function require minimally invasive surgical treatment, including those with lung cancer, benign lung tumors, pneumothorax, or lung volume reduction surgery. Patients with borderline lung function often cannot be extubated immediately postoperatively under conventional treatment models. These patients typically need to be transferred to the surgical ICU for close monitoring. However, positive-pressure mechanical ventilation with an endotracheal tube carries risks of further airway injury and persistent air leakage from the lung surface, leading to a high incidence of postoperative respiratory failure. Non-intubated minimally invasive surgery (tubeless), which preserves spontaneous breathing without endotracheal intubation, avoids the physical stimulation of intubation and the airway damage caused by mechanical ventilation. This approach may reduce the incidence of postoperative airway injury and respiratory failure, potentially expanding the indications for minimally invasive lung surgery, lowering postoperative complication and mortality rates. The aim is to further clarify the surgical indications for non-intubated single-port minimally invasive surgery in patients with impaired lung function, the decision-making criteria for postoperative ICU transfer, and the safety and feasibility of this comprehensive management approach.
Eligibility Criteria
Inclusion Criteria: 1. Patients with impaired lung function (who may require postoperative intubation and transfer to the surgical ICU after preoperative and MDT discussions). 2. Patients requiring minimally invasive lung resection due to lung cancer, pulmonary nodules, benign lung tumors, pneumothorax, lung volume reduction surgery, etc. 3. Patients with normal mental status who can cooperate with perioperative examinations, exercises, and physical rehabilitation measures. 4. Patients who agree to participate in the clinical trial after communication. Exclusion Criteria: 1. Patients with severe impairment of cardiopulmonary function or other organ systems, who are deemed unable to tolerate any form of anesthesia or minimally invasive surgery after preoperative and MDT discussions. 2. Patients with abnormal mental status or who are unable to adequately cooperate with perioperative examinations, exercises, and physical rehabilitation measures. 3. Patients who refuse to participate in the clinical trial or decline the use of non-intubated anesthesia with preserved spontaneous breathing. 4. Patients who refuse to undergo surgery.
Contact & Investigator
Yunpeng Zhao
PRINCIPAL INVESTIGATOR
The Second Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT06848751 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 85 Years, studying Lung Function Decreased. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06848751 currently recruiting?
Yes, NCT06848751 is actively recruiting participants. Contact the research team at zhaoyunpengsddx@sdu.edu.cn for enrollment information.
Where is the NCT06848751 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06848751 clinical trial?
NCT06848751 is sponsored by The Second Hospital of Shandong University. The principal investigator is Yunpeng Zhao at The Second Hospital of Shandong University. The trial plans to enroll 45 participants.