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Clinical Study of Lung Protective Ventilation Strategies and Tumor Microenvironment

Effect of Lung Protective Ventilation Strategy on Tumor Inflammatory Microenvironment and Its Associated Hematological Composite Index in Patients Undergoing Colorectal Cancer Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06230965
Enrollment
60
Registered
2024-01-30
Start date
2024-01-25
Completion date
2025-12-31
Last updated
2026-03-25

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

Conditions

Tumor Microenvironment

Keywords

Lung protective ventilation strategies, Tumor microenvironment, Colorectal cancer

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).

Interventions

They were divided into 2 groups: traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), with 30 cases in each group. In the conventional ventilation strategy group, the conventional ventilation strategies were followed: tidal volume (VT)=10-12ml/kg, respiratory rate(f) =12 times/minute, PEEP=0 cmH₂O, fraction of inspired oxygen=0.5; Lung protective ventilation strategies were implemented in the Lung protective ventilation strategy group: VT=6-8ml/kg, f=12 times/min, PEEP=6-8 cm H₂O,fraction of inspired oxygen=0.5 Manual lung reexpansion was performed every 30 minutes after mechanical ventilation (continuous positive airway pressure of 30 cm H₂O for 30 seconds).

Sponsors

Affiliated Hospital of Nantong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
51 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Microenvironment-related indicators of tumor inflammation10 minutes before anesthesia, 1 hour and 24 hours after the procedureConcentrations of tumor necrosis factor alpha (TNF-α)

Secondary

MeasureTime frameDescription
Comprehensive blood index10 minutes before anesthesia and 24 hours after the procedureValues for NLDA (NLDA = neutrophil count/lymphocyte count × D-dimer count/albumin)

Countries

China

Contacts

STUDY_DIRECTORYongtao Gao, Master

The Affiliated Hospital of Nantong University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026