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Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery

NCT ID: NCT02779595

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Postoperative pulmonary complications (Defined as pulmonary infection, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis or respiratory insufficiency subsequent to surgery) increase the morbidity and mortality of surgical patients. Several independent factors determined by the patients' characteristics and the operative procedure increase the risk for those complications. The postoperative decrease of values measured by spirometry, such as the forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), were found in patients after major surgical procedures for several days. The postoperative reduction of those measurement can be the result of general functional limitations in those patients (e.g. by postoperative pain) or the result of a regional postoperative pulmonary complication (e.g. atelectasis, pleural effusion). The method of the electrical impedance tomography (EIT) enables to visualize the regional ventilation within a transversal section of the lung in real time. Studies examining the change of pulmonary EIT for several days postoperatively in spontaneously breathing patients are lacking. The aim of the present study is to examine perioperative changes in regional ventilation in spontaneously breathing patients during their recovery after lung and flail chest surgery. Moreover, the association of those changes with expected changes in spirometry is tested. Finally, in patients with evident postoperative pulmonary complications the value of pulmonary EIT to detect those changes is investigated. The study should improve the knowledge about the development of postoperative pulmonary complications and test the scientific and clinical value of pulmonary EIT in those spontaneously breathing patients.

Conditions

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Pulmonary Infection Respiratory Insufficiency Aspiration Pneumonitis Bronchospasm Atelectasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Perioperative pulmonary function tests

Intervention Type OTHER

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

Flail chest

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

Perioperative pulmonary function tests

Intervention Type OTHER

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

Interventions

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Perioperative pulmonary function tests

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

Intervention Type OTHER

Eligibility Criteria

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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


* performed pneumonectomy
* Reoperation
* postoperative ventilation at the third day
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Markus Kredel, PD.Dr.med

Role: PRINCIPAL_INVESTIGATOR

University of Würzburg, Department of Anaesthesia and Critical Care

Locations

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University of Würzburg

Würzburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 21045639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24901240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8942326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20963310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23074580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22992946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22531334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23877309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9689281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21261780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25398109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18431279 (View on PubMed)

Other Identifiers

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thoraxEIT

Identifier Type: -

Identifier Source: org_study_id