Clinical Study of Lung Protective Ventilation Strategies and Tumor Microenvironment

Launched by AFFILIATED HOSPITAL OF NANTONG UNIVERSITY · Jan 26, 2024

Keywords

ClinConnect Summary

This study is looking at whether using a lung-protective ventilation approach during colorectal cancer surgery changes the tumor’s inflammatory environment and certain blood markers, compared with standard ventilation. In a randomized setup, 60 adults with colorectal cancer will be assigned to either conventional ventilation (higher tidal volume, no extra airway pressure) or lung-protective ventilation (lower tidal volume, added pressure support, with brief periodic lung expansion). During and after surgery, researchers will draw about 4 ml of central blood at three time points (10 minutes before anesthesia, 1 hour after, and 24 hours after) to measure inflammation-related indicators in the tumor environment, along with a secondary set of blood tests. The study is being conducted at The Affiliated Hospital of Nantong University in Nantong, China, led by Dr. Yongtao Gao, and results are not yet available.

Who may be eligible: adults typically aged about 51 to 70 years (up to 75) with a pathologic diagnosis of colorectal cancer, and who are generally healthy enough for surgery (ASA physical status II–III). They should have a body mass index between 18 and 30, normal heart and lung function before operation, and no preoperative anemia, current infection, or coagulation problems. People who have used immunosuppressants or had certain cancer therapies before surgery are not eligible. Participants will be randomly assigned to one of the two ventilation plans during surgery and will have follow-up assessments of frailty and recovery at 1, 3, 6, and 12 months after surgery. The trial is currently enrolling by invitation, with ongoing oversight and no current results released.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. pathologic diagnosis of Colorectal Cancer
• • 2. American society of Aneshesiologists（ASA）physical status classification system Grade Ⅱ-Ⅲ;
• • 3. From 51-70 years old with no gender restrictions
• • 4. Normal cardiopulmonary function before operation
• • 5. Body Mass Index:18-30
• Exclusion Criteria:
• • 1. Preoperative anemia (hemoglobin\<10g/dl)
• • 2. Patients with preoperative mechanical ventilation;
• • 3. A history of pulmonary infection and pulmonary tuberculosis within 1 month before surgery;
• • 4. Preoperative blood oxygen saturation (SpO₂) was less than 90% (SpO₂\<90%), or the oxygen partial pressure (PaO₂) was less than 90% (PaO₂\<60 mmHg), or PaO₂/fraction of inspired oxygen（FiO₂）ratio\<300 mmHg, or arterial blood carbon dioxide partial pressure (PaCO₂) was greater than 45 mmHg (PaCO₂\>45 mmHg);
• • 5. Patients who take immunosuppressants, neoadjuvant chemotherapy and radiotherapy before surgery;
• • 6. Preoperative abnormal coagulation function.