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

NCT06514729 | Recruiting DMC

• 1 other identifier: KLL-2023-216
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Injury; Lung Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group VCV+CPAP

EXPERIMENTAL

Ventilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side

Procedure: Adopting different ventilation modes during the operation

Group PCV+CPAP

EXPERIMENTAL

Ventilation side pressure control ventilation+continuous positive pressure ventilation on the non ventilation side

Procedure: Adopting different ventilation modes during the operation

Group PRVC+CPAP

EXPERIMENTAL

Ventilation side pressure regulated volume control ventilation+continuous positive pressure ventilation on the non ventilation side

Procedure: Adopting different ventilation modes during the operation

Interventions

Adopting different ventilation modes during the operation PROCEDURE

The ventilation side adopts different ventilation modes combined with continuous positive pressure ventilation on the surgical side.

Group PCV+CPAP; Group PRVC+CPAP; Group VCV+CPAP

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mao Enting: lead

Study Sites (1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

MeSH Terms

Conditions

Lung Injury; Pneumonia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Respiratory Tract Infections; Infections

Study Officials

• Pan Jiamei

  Staff member of Department of Anesthesiology,Affiliated Hospital of Zunyi Medical University

  STUDY DIRECTOR

• Zhang Hong

  Chief physician of Department of Anesthesiology,Affiliated Hospital of Zunyi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mao Enting

CONTACT

+0086 15736012002; 2432870509@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researchers in this study enrolled suitable patients using a random number table method before surgery, and then performed different intraoperative single lung ventilation modes according to the grouping after unblinding the patients upon entering the room. The postoperative follow-up personnel or data analysts are unaware of the grouping status.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology resident,Affiliate Hospital of Zunyi Medical University

Model Details: 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 Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data related to this trial can be shared for a total 6 months after publication.
• Access Criteria: Contact the head of the study for approval

Locations

CN (1)