Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery

NCT02779595 | Completed

• 1 other identifier: thoraxEIT
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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 lung and flail chest surgery.

Conditions

Pulmonary Infection; Respiratory Insufficiency; Aspiration Pneumonitis; Bronchospasm; Atelectasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lateral Change from baseline in regional ventilation depending on side of surgery

  baseline and 3. postoperative day

Other Outcomes (5)

• Association between lateral change of regional ventilation and change of forced vital capacity

  baseline, 3., 5. and 7. postoperative day

• Sagittal change from baseline in regional ventilation

  baseline, 3., 5. and 7. postoperative day

• Association between sagittal change of regional ventilation and change of forced vital capacity

  baseline, 3., 5. and 7. postoperative day

Study Arms (2)

Lung surgery

26 patients (up to 36) undergoing lung surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests

Other: Perioperative pulmonary function tests

Flail chest

8 patients undergoing an operative stabilization of a flail chest will be examined by perioperative pulmonary function tests

Other: Perioperative pulmonary function tests

Interventions

Perioperative pulmonary function tests OTHER

Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the the third, fifth and seventh postoperative day

Flail chest; Lung surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult inpatients undergoing elective surgery

You may qualify if:

• Adult
• Inpatient
• Lung surgery under general anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University of Würzburg

Würzburg, 97080, Germany

Location

Related Publications (12)

• 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.

  PMID: 21045639 BACKGROUND

• 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.

  PMID: 24901240 BACKGROUND

• 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.

  PMID: 8942326 BACKGROUND

• 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.

  PMID: 20963310 BACKGROUND

• 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.

  PMID: 23074580 BACKGROUND

• 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.

  PMID: 22992946 BACKGROUND

• 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.

  PMID: 22531334 BACKGROUND

• 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.

  PMID: 23877309 BACKGROUND

• 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.

  PMID: 9689281 BACKGROUND

• Reifferscheid F, Elke G, Pulletz S, Gawelczyk B, Lautenschlager 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.

  PMID: 21261780 BACKGROUND

• 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. No abstract available.

  PMID: 25398109 BACKGROUND

• Wrigge H, Zinserling J, Muders T, Varelmann D, Gunther 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.

  PMID: 18431279 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Pneumonia, Aspiration; Bronchial Spasm; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Bronchial Diseases

Study Officials

• Markus Kredel, PD.Dr.med

  University of Würzburg, Department of Anaesthesia and Critical Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 20, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)