Clinical Study of Lung Protective Ventilation Strategies and Tumor Microenvironment

NCT06230965 | Completed DMC

• 1 other identifier: LPVS-MS2023025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Tumor Microenvironment

Keywords

Lung protective ventilation strategies; Tumor microenvironment; Colorectal cancer

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• Comprehensive blood index

  10 minutes before anesthesia and 24 hours after the procedure

• Comprehensive blood index

  10 minutes before anesthesia and 24 hours after the procedure

• Comprehensive blood index

  10 minutes before anesthesia and 24 hours after the procedure

• Comprehensive blood index

  10 minutes before anesthesia and 24 hours after the procedure

Study Arms (2)

conventional ventilation strategy group

OTHER

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

lung protective ventilation strategy group

EXPERIMENTAL

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

Interventions

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).

Also known as: conventional ventilation strategy

conventional ventilation strategy group; lung protective ventilation strategy group

Eligibility Criteria

• Age: 51 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

The Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yongtao Gao, Master

  The Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 30, 2024
• Study Start: January 25, 2024
• Primary Completion: February 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 25, 2026

Record last verified: 2025-09

Locations

CN (1)