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

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).

Study Overview

• Status: Completed
• Conditions: Tumor Microenvironment
• Intervention / Treatment: Procedure: Lung protective ventilation strategy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • The Affiliated Hospital of Nantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: conventional ventilation strategy group; The conventional ventilation strategy group used a conventional ventilation strategies: tidal volume（VT）=10-12 ml/kg, respiratory rate（f）=12 beats/minute, end-expiratory positive pressure（PEEP）= 0 cm H₂O, fraction of inspired oxygen = 0.5	Procedure: Lung protective ventilation strategy; 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).; Other Names: conventional ventilation strategy
Experimental: lung protective ventilation strategy group; The lung protective ventilation strategy group used the lung protective ventilation strategies : tidal volume（VT）=6-8 ml/kg, f=12 breaths / minute,end-expiratory positive pressure（PEEP） = 6-8 cmH₂O, and fraction of inspired oxygen = 0.5 . After mechanical ventilation every 30 minutes (continuous positive airway pressure 30 cmH₂O for 30 seconds).	Procedure: Lung protective ventilation strategy; 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).; Other Names: conventional ventilation strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microenvironment-related indicators of tumor inflammation	Concentrations of tumor necrosis factor alpha (TNF-α)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation	Concentrations of nucleartranscriptionfactorkappaB (NF-kB)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation	Concentrations of interleukin-6 (IL-6)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation	Concentrations of Tumor-associated macrophages (TAMs)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation	Concentrations of vascular endothelial growth factor (VEGF)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation	Concentrations of Janus Kinase 1 (JAK1)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation	Concentrations of signal transducer and activator of transcription 3 (STAT3)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation	Concentrations of Protooncogene tyrosine protein kinase (C-Src)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation	Concentrations of matrix metalloproteinases 2 (MMP-2)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure
Microenvironment-related indicators of tumor inflammation	Concentrations of matrix metalloproteinases 9 (MMP-9)	10 minutes before anesthesia, 1 hour and 24 hours after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive blood index	Values for NLDA (NLDA = neutrophil count/lymphocyte count × D-dimer count/albumin)	10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index	Values for PDM (PDM = platelet× D-dimer count)	10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index	Values for SII (SII= platelet× neutrophil / lymphocyte count)	10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index	Values for PNI (PNI = albumin + 5 × lymphocytes)	10 minutes before anesthesia and 24 hours after the procedure

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Study Director: Yongtao Gao, Master, The Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Colorectal cancer; Tumor microenvironment; Lung protective ventilation strategies
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: LPVS-MS2023025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No