Inflammation After One Lung Ventilation (NCT02188407) | Clinical Trial Compass
CompletedPhase 1
Inflammation After One Lung Ventilation
Slovenia40 participantsStarted 2008-07
Plain-language summary
The aim of the study was to prospectively investigate the influence of one-lung ventilation (OLV) on the inflammatory response and to identify possible antiinflammatory effects of the volatile anaesthetic sevoflurane.
Forty patients undergoing thoracic surgery with OLV were enrolled in this prospective, randomised study. The patients were randomly allocated into two groups to receive either propofol (Group P) or sevoflurane (Group S) for induction and maintenance of anaesthesia.
Inflammatory mediators (Interleukin 6 (IL6), Interleukin8 (IL8), Interleukin 10 (IL10), (C- reactive protein)CRP) were measured intra- and postoperatively.
Six hours after surgery oxygenation index (PaO2/FiO2) was calculated and chest X ray was taken and assessed.
The clinical outcome determinated by postoperative adverse events was assessed as the secondary endpoint.
Who can participate
Age range
20 Years – 70 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:
* Patients aged 20-70 years
* American Society of Anaesthesiologists (ASA) physical status I-III
* elective open lobectomy with OLV
Exclusion Criteria:
* history of drug hypersensitivity
* drug addiction
* treatment with psychotropic drugs
* severe psychiatric and central nerve system diseases
* persistent tobacco abuse, autoimmune system diseases
* diabetes mellitus
* cardiac failure (New York Heart Association class greater than 2)
* clinically relevant obstructive and restrictive lung diseases (vital capacity or forced expiratory volume in 1s lover than 50% of the predicted values)
* pulmonary hypertension (mean pulmonary arterial pressure grater than 25 mmHg)
* pre-existing coagulation disorders
* history of treatment with immunosuppressant drugs in the 4 weeks before surgery
* Patient with evidence of pulmonary or systemic infections (C-reactive protein serum concentration greater than 5 mg/L, leucocytosis greater than 10.0 bioparticles/L or body temperature greater than 37 stC)
* perioperative blood derivatives, steroids or non-steroidal anti-inflammatory drug (NSAID)
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
IL 6
Timeframe: intraoperatively and 6 hours after surgery