- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06514729
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mao Enting
- Phone Number: +0086 15736012002
- Email: 2432870509@qq.com
Study Locations
-
-
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
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
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
|
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
|
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
|
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
Time Frame: Within 15 days after surgery
|
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
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)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KLL-2023-216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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