Skip to main content
OpenTrials
Completed

NCT Number: NCT06230965

Clinical Study of Lung Protective Ventilation Strategies and Tumor Microenvironment

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

51 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pathologic diagnosis of Colorectal Cancer
  • American society of Aneshesiologists(ASA)physical status classification system Grade Ⅱ-Ⅲ;
  • From 51-70 years old with no gender restrictions
  • Normal cardiopulmonary function before operation
  • Body Mass Index:18-30

Exclusion criteria

  • Preoperative anemia (hemoglobin<10g/dl)
  • Patients with preoperative mechanical ventilation;
  • A history of pulmonary infection and pulmonary tuberculosis within 1 month before surgery;
  • 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);
  • Patients who take immunosuppressants, neoadjuvant chemotherapy and radiotherapy before surgery;
  • Preoperative abnormal coagulation function.

Treatment and study plan

lung protective ventilation strategy

Procedure

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

Primary outcomes

  1. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of tumor necrosis factor alpha (TNF-α)

  2. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of nucleartranscriptionfactorkappaB (NF-kB)

  3. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of interleukin-6 (IL-6)

  4. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of Tumor-associated macrophages (TAMs)

  5. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of vascular endothelial growth factor (VEGF)

  6. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of Janus Kinase 1 (JAK1)

  7. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of signal transducer and activator of transcription 3 (STAT3)

  8. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of Protooncogene tyrosine protein kinase (C-Src)

  9. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of matrix metalloproteinases 2 (MMP-2)

  10. Microenvironment-related indicators of tumor inflammation

    Time frame: 10 minutes before anesthesia, 1 hour and 24 hours after the procedure

    Concentrations of matrix metalloproteinases 9 (MMP-9)

Secondary outcomes

  1. Comprehensive blood index

    Time frame: 10 minutes before anesthesia and 24 hours after the procedure

    Values for NLDA (NLDA = neutrophil count/lymphocyte count × D-dimer count/albumin)

  2. Comprehensive blood index

    Time frame: 10 minutes before anesthesia and 24 hours after the procedure

    Values for PDM (PDM = platelet× D-dimer count)

  3. Comprehensive blood index

    Time frame: 10 minutes before anesthesia and 24 hours after the procedure

    Values for SII (SII= platelet× neutrophil / lymphocyte count)

  4. Comprehensive blood index

    Time frame: 10 minutes before anesthesia and 24 hours after the procedure

    Values for PNI (PNI = albumin + 5 × lymphocytes)

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.