Clinical Study of Lung Protective Ventilation Strategies and Tumor Microenvironment

March 23, 2026 updated by: Yongtao Gao, Affiliated Hospital of Nantong University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
10 minutes before anesthesia, 1 hour and 24 hours after the procedure
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)
10 minutes before anesthesia, 1 hour and 24 hours after the procedure
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)
10 minutes before anesthesia, 1 hour and 24 hours after the procedure
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)
10 minutes before anesthesia, 1 hour and 24 hours after the procedure
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)
10 minutes before anesthesia, 1 hour and 24 hours after the procedure
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)
10 minutes before anesthesia, 1 hour and 24 hours after the procedure
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)
10 minutes before anesthesia, 1 hour and 24 hours after the procedure
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)
10 minutes before anesthesia, 1 hour and 24 hours after the procedure
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 minutes before anesthesia, 1 hour and 24 hours after the procedure
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)
10 minutes before anesthesia, 1 hour and 24 hours after the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index
Time Frame: 10 minutes before anesthesia and 24 hours after the procedure
Values for PDM (PDM = platelet× D-dimer count)
10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index
Time Frame: 10 minutes before anesthesia and 24 hours after the procedure
Values for SII (SII= platelet× neutrophil / lymphocyte count)
10 minutes before anesthesia and 24 hours after the procedure
Comprehensive blood index
Time Frame: 10 minutes before anesthesia and 24 hours after the procedure
Values for PNI (PNI = albumin + 5 × lymphocytes)
10 minutes before anesthesia and 24 hours after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated Hospital of Nantong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yongtao Gao, Master, The Affiliated Hospital of Nantong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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