Respiratory Insufficiency Clinical Trial
Official title:
Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery
Verified date | November 2017 |
Source | Wuerzburg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 lung and flail chest surgery.
Status | Completed |
Enrollment | 31 |
Est. completion date | August 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult - Inpatient - Lung surgery under general anaesthesia Exclusion Criteria: - Missing informed consent - Outpatient - Emergency procedure - Revision surgery of hospitalized patients - Pneumothorax - Pleural effusion - Pleural effusion or pleural empyema with need to cannulate - scheduled Pneumonectomy - 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 Exclusion criteria during clinical course: - performed pneumonectomy - Reoperation - postoperative ventilation at the third day |
Country | Name | City | State |
---|---|---|---|
Germany | University of Würzburg | Würzburg |
Lead Sponsor | Collaborator |
---|---|
Wuerzburg University Hospital |
Germany,
Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté 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. — View Citation
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. — View Citation
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. — View Citation
Guerin C, Frerichs I. Getting a better picture of the correlation between lung function and structure using electrical impedance tomography. Am J Respir Crit Care Med. 2014 Nov 15;190(10):1186-7. doi: 10.1164/rccm.201405-0812IM. — View Citation
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. Epub 2010 Oct 15. English, Portuguese. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Mazo V, Sabaté 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. — View Citation
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. — View Citation
Reifferscheid F, Elke G, Pulletz S, Gawelczyk B, Lautenschläger I, Steinfath M, Weiler N, Frerichs I. Regional ventilation distribution determined by electrical impedance tomography: reproducibility and effects of posture and chest plane. Respirology. 2011 Apr;16(3):523-31. doi: 10.1111/j.1440-1843.2011.01929.x. — View Citation
Wrigge H, Zinserling J, Muders T, Varelmann D, Günther U, von der Groeben C, Magnusson A, Hedenstierna G, Putensen C. Electrical impedance tomography compared with thoracic computed tomography during a slow inflation maneuver in experimental models of lung injury. Crit Care Med. 2008 Mar;36(3):903-9. doi: 10.1097/CCM.0B013E3181652EDD. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Association between lateral change of regional ventilation and change of forced vital capacity | Correlation testing is done on the ipsi- and contralateral change in the calculated 'Center of Ventilation' and the forced vital capacity in % of normal (FVC%) by spirometry | baseline, 3., 5. and 7. postoperative day | |
Other | Sagittal change from baseline in regional ventilation | Regional ventilation is measured by pulmonary electrical impedance tomography. The sagittal change in the calculated 'Center of Ventilation' is evaluated | baseline, 3., 5. and 7. postoperative day | |
Other | Association between sagittal change of regional ventilation and change of forced vital capacity | Correlation testing is done sagittal change in the calculated 'Center of Ventilation' and the forced vital capacity in % of normal (FVC%) by spirometry | baseline, 3., 5. and 7. postoperative day | |
Other | Time shift in regional ventilation between ipsi- and contralateral lung | Regional ventilation is measured by pulmonary electrical impedance tomography. The shift in time of occurence of ipsi- and contralateral Ventilation is evaluated | baseline, 3., 5. and 7. postoperative day | |
Other | Impact on flail chest surgery to change from baseline in regional ventilation | Measured by EIT | baseline, 3., 5. and 7. postoperative day | |
Primary | Lateral Change from baseline in regional ventilation | Regional ventilation is measured by pulmonary electrical impedance tomography. The ipsi- and contralateral change in the calculated 'Center of Ventilation' is evaluated | baseline and 3. postoperative day | |
Secondary | Lateral Change from baseline in regional ventilation depending on side of surgery | Regional ventilation is measured by pulmonary electrical impedance tomography. The influence of the side of surgery on the ipsi- and contralateral change in the calculated 'Center of Ventilation' is evaluated | baseline and 3. postoperative day |
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