Clinical Study of Lung Protective Ventilation Strategies and Tumor Microenvironment

Not Applicable

• Conditions: Tumor Microenvironment

• Registration Number: NCT06230965
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief Summary

This study will be conducted in the Affiliated Hospital of Nantong University. Sixty colorectal cancer(CRC) patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. The control group adopted conventional ventilation strategy; the experimental group used lung protective ventilation strategy. 4ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. Observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes in patients undergoing colorectal cancer surgery. Follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (QoR-15 score scale).

Detailed Description

This study will be conducted in the Affiliated Hospital of Nantong University. Sixty CRC patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. The control group adopted conventional ventilation strategies: tidal volume (VT)=10-12 ml/kg, respiratory rate ( f)=12 breaths / minute, positive end expiratory pressure（PEEP）=0 cmH₂O, fraction of inspired oxygen =0.5; the experimental group used lung protective ventilation strategies: tidal volume ( VT)=6-8 ml/kg, f=12 breaths / minute, positive end expiratory pressure (PEEP)=6-8 cmH₂O, fraction of inspired oxygen =0.5, mechanical ventilation every 30 minutes (continuous positive airway pressure 30 cmH₂O about 30 seconds). 4 ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. Observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes NLDA, PDM, SII and PNI in patients undergoing colorectal cancer surgery. Follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (QoR-15 score scale).

Study Timeline

• Study First Submitted: 2024-01-09
• Study Start: 2024-01-25
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-01-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Microenvironment-related indicators of tumor inflammation	10 minutes before anesthesia, 1 hour and 24 hours after the procedure	Concentrations of matrix metalloproteinases 9 (MMP-9)

Secondary Outcome Measures

Name	Time	Method
Comprehensive blood index	10 minutes before anesthesia and 24 hours after the procedure	Values for PNI (PNI = albumin + 5 × lymphocytes)

Trial Locations

Locations (1)

The Affiliated hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China