Tubeless Surgery With Impaired Pulmonary Function

NCT06848751 | Recruiting DMC

• 1 other identifier: TRIP-ZYP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Function Decreased; Surgery

Outcome Measures

Primary Outcomes (1)

• complication rate

  complication rate after surgery

  within 30 days after surgery

Study Arms (1)

tubeless group

EXPERIMENTAL

Non-intubated thoracoscopic surgery for lung leisions in patients with impaired pulmonary function

Procedure: Non-intubated thoracoscopic surgery

Interventions

Non-intubated thoracoscopic surgery PROCEDURE

Non-intubated thoracoscopic lung surgery for patients with impaired pulmonary function

tubeless group

Eligibility Criteria

• Age: 14 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with impaired lung function (who may require postoperative intubation and transfer to the surgical ICU after preoperative and MDT discussions).
• Patients requiring minimally invasive lung resection due to lung cancer, pulmonary nodules, benign lung tumors, pneumothorax, lung volume reduction surgery, etc.
• Patients with normal mental status who can cooperate with perioperative examinations, exercises, and physical rehabilitation measures.
• Patients who agree to participate in the clinical trial after communication.

You may not qualify if:

• 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.
• Patients with abnormal mental status or who are unable to adequately cooperate with perioperative examinations, exercises, and physical rehabilitation measures.
• Patients who refuse to participate in the clinical trial or decline the use of non-intubated anesthesia with preserved spontaneous breathing.
• Patients who refuse to undergo surgery.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Yunpeng Zhao

  The Second Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunpeng Zhao

CONTACT

18766188692; zhaoyunpengsddx@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: April 10, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

CN (1)