Lung InjuryNCT06514729
The Effects of Different Ventilation Modes on Patients With Pulmonary Lobe Resection
A study testing Adopting different ventilation modes during the operation in people with Lung Injury and Lung Inflammation, run by Mao Enting at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Injury, Lung Inflammation
- What is being tested?
- Adopting different ventilation modes during the operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Mao Enting, +0086 15736012002, 2432870509@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Injury, Lung Inflammation
- Being tested
- Adopting different ventilation modes during the operation
- Medical subject headings
- Lung Injury, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adopting different ventilation modes during the operationProcedure or surgery
The ventilation side adopts different ventilation modes combined with continuous positive pressure ventilation on the surgical side.
| Study group | Role | What they receive |
|---|---|---|
| Group VCV+CPAP | Experimental | Ventilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side Receives: 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 Receives: 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 Receives: Procedure: Adopting different ventilation modes during the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 15 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jan 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mao Enting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mao Enting, Zunyi Medical College
- Investigators
- Pan Jiamei, Study director, Staff member of Department of Anesthesiology,Affiliated Hospital of Zunyi Medical UniversityZhang Hong, Principal investigator, Chief physician of Department of Anesthesiology,Affiliated Hospital of Zunyi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514729
- Sponsor's protocol ID
- KLL-2023-216
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the clinical trial , each groups and its clinical pulmonary Infection score were shared with other research teams.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Ventilation Modes on Patients With Plasma Inflammatory Factor and Respiratory Function in Patients With Pulmonary Lobe Resection
- ClinicalTrials.gov ID
- NCT06514729
- Acronym / sponsor ID
- KLL-2023-216
- Conditions
- Lung Injury, Lung Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Mao EntingUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group VCV+CPAP | Experimental | Procedure: Adopting different ventilation modes during the operationVentilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side |
| Group PCV+CPAP | Experimental | Procedure: Adopting different ventilation modes during the operationVentilation side pressure control ventilation+continuous positive pressure ventilation on the non ventilation side |
| Group PRVC+CPAP | Experimental | Procedure: Adopting different ventilation modes during the operationVentilation side pressure regulated volume control ventilation+continuous positive pressure ventilation on the non ventilation side |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adopting different ventilation modes during the operationThe ventilation side adopts different ventilation modes combined with continuous positive pressure ventilation on the surgical side. | Procedure or surgery | Group PCV+CPAP, Group PRVC+CPAP, Group VCV+CPAP |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes. After the clinical trial , each groups and its clinical pulmonary Infection score were shared with other research teams.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pan Jiamei study director
Staff member of Department of Anesthesiology,Affiliated Hospital of Zunyi Medical University
Zhang Hong principal investigator
Chief physician of Department of Anesthesiology,Affiliated Hospital of Zunyi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adopting different ventilation modes during the operation in people with Lung Injury and Lung Inflammation, run by Mao Enting at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mao Enting (+0086 15736012002, 2432870509@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pulmonary Infection Score (time frame: Within 15 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.