Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic A… (NCT01504893) | Clinical Trial Compass
CompletedNot Applicable
Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia
Italy984 participantsStarted 2013-09
Plain-language summary
The purpose of this study is to determine if a protective ventilatory strategy during one-lung ventilation (OLV) based on low tidal volume, PEEP and alveolar recruitment maneuver can reduce Acute Respiratory Distress Syndrome (ARDS) and Postoperative pulmonary complications (PPCs) after major pulmonary resection.
Primary endpoint: Evaluation of postoperative ARDS incidence
Secondary endpoint: Evaluation od PPC incidence and postoperative outcomes (other complications, unplanned Intensive Care Admission, hospital and ICU length of stay, in-hospital mortality)
Who can participate
Age range
18 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 ≥ 18 years
* ASA IV
* Elective thoracotomies or thoracoscopic major lung resection surgery (lobectomy, bilobectomy, pneumonectomy)
Exclusion Criteria:
* Emergency surgery
* Wedge resection or atypical resection
* Non-resective lung surgery requiring OLV
* Patients \< 18 years
* BMI \< 20 and BMI \> 29
* Heart disease with ejection fraction \<50% and/or severe valvulopathy
* Pulmonary hypertension
* Renal failure requiring dialytic treatment
* Drug addiction
* Mental retardation, depression and psychiatric disease
* Motor or sensory deficit
* Pregnancy
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.