Perioperative Change of Regional Ventilation During Spontaneous Breathing
NCT ID: NCT02419196
Last Updated: 2016-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
72 participants
OBSERVATIONAL
2015-01-31
2016-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery
NCT02779595
Perioperative Lung Function Monitoring After Anatomic Lung Resections
NCT03054675
Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD
NCT02566343
Influence of Posture and Gas Insufflation on Perioperative Lung Function
NCT00948571
Preoperative Inspiratory Muscle Training in Esophageal Resection
NCT01893008
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In a group of patients undergoing osteosynthesis of a flail chest, it is tested how regional ventilation changes by these operations and whether pulmonary EIT is actually usable in these patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
abdominal surgery
27 patients undergoing abdominal surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests
Perioperative pulmonary function tests
Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
limb surgery
27 patients undergoing upper and lower limb surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests
Perioperative pulmonary function tests
Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
flail chest
10 patients undergoing an operative stabilization of a flail chest will be examined by perioperative pulmonary function tests
Perioperative pulmonary function tests
Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Perioperative pulmonary function tests
Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wuerzburg University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Markus Kredel, PD. Dr. med
Role: PRINCIPAL_INVESTIGATOR
University of Würzburg, Department of Anaesthesia and Critical Care
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Würzburg
Würzburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.
Karayiannakis AJ, Makri GG, Mantzioka A, Karousos D, Karatzas G. Postoperative pulmonary function after laparoscopic and open cholecystectomy. Br J Anaesth. 1996 Oct;77(4):448-52. doi: 10.1093/bja/77.4.448.
Guizilini S, Bolzan DW, Faresin SM, Alves FA, Gomes WJ. Ministernotomy in myocardial revascularization preserves postoperative pulmonary function. Arq Bras Cardiol. 2010 Oct;95(5):587-93. doi: 10.1590/s0066-782x2010005000137. Epub 2010 Oct 15. English, Portuguese.
Davoudi M, Farhanchi A, Moradi A, Bakhshaei MH, Safarpour G. The Effect of Low Tidal Volume Ventilation during Cardiopulmonary Bypass on Postoperative Pulmonary Function. J Tehran Heart Cent. 2010 Summer;5(3):128-31. Epub 2010 Aug 31.
Leonhardt S, Lachmann B. Electrical impedance tomography: the holy grail of ventilation and perfusion monitoring? Intensive Care Med. 2012 Dec;38(12):1917-29. doi: 10.1007/s00134-012-2684-z. Epub 2012 Sep 20.
Radke OC, Schneider T, Heller AR, Koch T. Spontaneous breathing during general anesthesia prevents the ventral redistribution of ventilation as detected by electrical impedance tomography: a randomized trial. Anesthesiology. 2012 Jun;116(6):1227-34. doi: 10.1097/ALN.0b013e318256ee08.
Karsten J, Heinze H, Meier T. Impact of PEEP during laparoscopic surgery on early postoperative ventilation distribution visualized by electrical impedance tomography. Minerva Anestesiol. 2014 Feb;80(2):158-66. Epub 2013 Jul 23.
Frerichs I, Hahn G, Golisch W, Kurpitz M, Burchardi H, Hellige G. Monitoring perioperative changes in distribution of pulmonary ventilation by functional electrical impedance tomography. Acta Anaesthesiol Scand. 1998 Jul;42(6):721-6. doi: 10.1111/j.1399-6576.1998.tb05308.x.
Bauer M, Opitz A, Filser J, Jansen H, Meffert RH, Germer CT, Roewer N, Muellenbach RM, Kredel M. Perioperative redistribution of regional ventilation and pulmonary function: a prospective observational study in two cohorts of patients at risk for postoperative pulmonary complications. BMC Anesthesiol. 2019 Jul 27;19(1):132. doi: 10.1186/s12871-019-0805-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
perioperativeEIT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.