Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography (NCT02337673) | Clinical Trial Compass
CompletedNot Applicable
Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography
Germany130 participantsStarted 2014-05
Plain-language summary
The purpose of this study is to determine whether Electrical Impedance Tomography can be used as sensitive and specific predictor in the detection of postoperative pulmonary complications (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion, pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia, spasms and obstructions of the airway) in patients undergoing epigastric surgery.
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:
* age \> 17 years
* no participation in another trial
* mental and physical state allow written consent
* elective epigastric surgery by laparotomy in general anesthesia (e.g. gastrectomy, splenectomy, pancreatic surgery, liver surgery/hemihepatectomy, cholecystectomy)
Exclusion Criteria:
* age \< 18 years
* in women: pregnancy
* missing or disability for giving written consent
* emergency patients
* patients after cardiac surgery less than 3 months ago
* patients after pulmonary lobectomy during lifetime
* patients with cardiac stimulator/defibrillator or any other implant with electric activity
* patients with cutaneous lesions or bandage in the area of EIT electrode placement
* patients with instability of the spine
* body mass index \> 50
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
Change of regional ventilation partition (ROI analysis in 8 pulmonary ROIs) from preoperative to postoperative state.
Timeframe: 1.) First EIT-measure: Preoperative Day; 2.) Second EIT-measure: Day of Operation (after extubation) or in between Postoperative Day 1-7 (in case of deferred extubation)