Effects of Permissive Hypercapnia During Lung Surgery on Inflammatory Biomarkers in Serum and Bro… (NCT07749456) | Clinical Trial Compass
CompletedNot Applicable
Effects of Permissive Hypercapnia During Lung Surgery on Inflammatory Biomarkers in Serum and Bronchoalveolar Lavage Fluid
40 participantsStarted 2015-06-01
Plain-language summary
The primary objective was to evaluate the effects of permissive hypercapnia on inflammatory biomarkers in bronchoalveolar lavage fluid and serum during one-lung ventilation. The secondary objective was to assess the influence of different ventilation modes on these inflammatory responses.
Methods: Forty patients undergoing elective lung surgery requiring OLV were prospectively enrolled an allocated to either a normocapnic (n=20) or hypercapnic group group (n=20). BAL concentrations of TNF-α, IL-1β, IL-6, and IL-8 were measured before and after intervention. Serum IL-6, C-reactive protein (CRP), and leukocyte counts were also assessed. Patients were further stratified according to ventilation mode (PC or VC).
Outcome measures: Primary outcome: change of bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α , IL-1β, IL-6, and IL-8) as well as in serum (IL-6, CRP, and WBC) between the normocapnic and hypercapnic groups during one-lung ventilation. Secondary outcome: whether the inflammatory response differed according to the ventilation mode (pressure-controlled versus volume-controlled ventilation).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eligible participants were aged 18-85 years,
* classified as American Society of Anesthesiologists (ASA) physical status I-III, --scheduled for procedures expected to last at least 60 minutes, with anticipated OLV for the the majority of the intraoperative period.
Exclusion Criteria:
* body mass index (BMI) \> 35 kg/m2;
* impaired pulmonary function (vital capacity of forced expiratory volume in 1 second (FEV1) \< 50% of predicted values);
* chronic infection;
* intracranial hypertension;
* prior intracranial hemorrhage;
* presence of active extrapulmonary malignancy;
* chronic pulmonary diseases (including chronic pneumonia, pneumoconiosis and silicosis);
* pulmonary hypertension;
* severe chronic obstructive pulmonary disease (COPD) with chronic hypercapnia;
* patients undergoing bilobectomy or pneumonectomy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of permissive hypercapnia on the inflammatory response during one-lung ventilation
Timeframe: After induction of anesthesia and at the end of surgery