The Effects of Different Ventilation Modes on Patients With Pulmonary Lobe Resection

The Effects of Different Ventilation Modes on Patients With Plasma Inflammatory Factor and Respiratory Function in Patients With Pulmonary Lobe Resection

The objective of this study was to discuss the effects of different ventilation modes on patients with plasma inflammatory factor and respiratory function in patients with pulmonary removal.

Study Overview

• Status: Recruiting
• Conditions: Lung Injury; Lung Inflammation
• Intervention / Treatment: Procedure: Adopting different ventilation modes during the operation

Detailed Description

Patients who meet the inclusion criteria will be numbered in the order of admission, and a dedicated person will prepare codes and opaque envelopes for random allocation. This study was divided into 3 groups, one groups was ventilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side, the other groups was ventilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side; the other groups was ventilation side pressure regulated volume control ventilation+continuous positive pressure ventilation on the non ventilation side.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mao Enting; Phone Number: +0086 15736012002; Email: 2432870509@qq.com

Study Locations

• China
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Recruiting
      • Affiliated Hospital of Zunyi Medical University
      • Contact: Mao Enting; Phone Number: +0086 15736012002; Email: 2432870509@qq.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Comprehensive examination and analysis of imaging, laboratory examination and other comprehensive examinations, the diagnosis is clear, which is in line with lobe resection surgical indications

Age 18-75 years old, the gender is not limited;

ASA grading Ⅰ ~ III level;

It is expected that the single lung ventilation time is ≥1 hours, and ≤3 hours

Exclusion Criteria:

Emergency surgery;

There is a taboos on the existence of systemic anesthesia;

There is a history of acute chronic upper respiratory infections in the past January;

Previous bronchial asthma, chronic obstructive pulmonary disease, bronchial dilatation, phthisis ,aspergillosis , acute respiratory distress syndrome or history of respiratory failure;

Merge the function of important organs such as heart, liver, and kidney;

There was a history of chest surgery and the history of trauma;

Preoperative lung function test obvious abnormal abnormal abnormalities (1 second of exhalation (FEV1) <60%);

Patients refuse to participate in the clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group VCV+CPAP; Ventilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side	Procedure: Adopting different ventilation modes during the operation; The ventilation side adopts different ventilation modes combined with continuous positive pressure ventilation on the surgical side.
Experimental: Group PCV+CPAP; Ventilation side pressure control ventilation+continuous positive pressure ventilation on the non ventilation side	Procedure: Adopting different ventilation modes during the operation; The ventilation side adopts different ventilation modes combined with continuous positive pressure ventilation on the surgical side.
Experimental: Group PRVC+CPAP; Ventilation side pressure regulated volume control ventilation+continuous positive pressure ventilation on the non ventilation side	Procedure: Adopting different ventilation modes during the operation; The ventilation side adopts different ventilation modes combined with continuous positive pressure ventilation on the surgical side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pulmonary Infection Score	The clinical pulmonary infection score index is mainly used to evaluate the severity of pulmonary infection, which involves many factors, including: body temperature, white blood cell count, tracheal secretions, oxygenation, X-ray chest X-ray, and the progress of pulmonary infiltrates. The maximum score is 12 points, and the severity of infection is directly proportional to its score.	Within 15 days after surgery

Collaborators and Investigators

• Sponsor: Mao Enting
• Investigators: Study Director: Pan Jiamei, Staff member of Department of Anesthesiology,Affiliated Hospital of Zunyi Medical University; Principal Investigator: Zhang Hong, Chief physician of Department of Anesthesiology,Affiliated Hospital of Zunyi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Inflammation; Pneumonia; Lung Injury
• Other Study ID Numbers: KLL-2023-216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the clinical trial , each groups and its clinical pulmonary Infection score were shared with other research teams.
• IPD Sharing Time Frame: Data related to this trial can be shared for a total 6 months after publication.
• IPD Sharing Access Criteria: Contact the head of the study for approval
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No