Clinical Study of Lung Protective Ventilation Strategies and Tumor Microenvironment

NCT ID: NCT06230965

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2025-12-31

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).

Conditions

Tumor Microenvironment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: OTHER

Lung protective ventilation strategy

Intervention Type: 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).

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).

Group Type: EXPERIMENTAL

Lung protective ventilation strategy

Intervention Type: 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).

Interventions

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).

Intervention Type: PROCEDURE

Other Intervention Names

conventional ventilation strategy

Eligibility Criteria

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.

• Minimum Eligible Age: 51 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Yongtao Gao

Head of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongtao Gao, Master

Role: STUDY_DIRECTOR

The Affiliated Hospital of Nantong University

Locations

The Affiliated hospital of Nantong University

Nantong, Jiangsu, China

Countries

China

Other Identifiers

LPVS-MS2023025

Identifier Type: -

Identifier Source: org_study_id