CompletedNot Applicable

Perioperative Change of Regional Ventilation During Spontaneous Breathing

Germany72 participantsStarted 2015-01

Plain-language summary

Perioperative changes in regional ventilation by pulmonary electrical impedance tomography and spirometry will be investigated in patients at risk for postoperative pulmonary complications. Those patients undergo abdominal and limb operations. In a pilot study arm electrical impedance tomography is tested in patients receiving osteosynthesis of serial rib fractures.

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: * Adult * Inpatient * Surgery under general anesthesia with and without additional regional anesthesia * increased risk for postoperative pulmonary complications according to the ARISCAT-Score (except pilot arm for osteosynthesis of flail chest) Exclusion Criteria: * Missing informed consent * Outpatient * Emergency procedure * Revision surgery of hospitalized patients * Operation under local or regional anesthesia alone * Expected postoperative ventilation * Expected hospital stay of less than three days * Pregnancy * Allergy against material of the electrode belt (silicone rubber, stainless steel, gold-plated brass) * Injured, inflamed or otherwise affected skin within the target region of the electrode belt * Unstable spine injury * Body mass index of more than 50 kg/m2 * Incapacity to lie quietly for the examination * Pacemaker, defibrillator or other active implant * Reoperation before the examination at the third postoperative day

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

Change from baseline in regional ventilation at the first postoperative day

Timeframe: baseline and 1. postoperative day

Change from baseline in regional ventilation at the third postoperative day

Timeframe: baseline and 3. postoperative day

Trial details

NCT IDNCT02419196

SponsorWuerzburg University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-02

View on ClinicalTrials.gov More Pulmonary Infection trials