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AzTrials

Pulmonary InfectionNCT02779595

Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery

An observational study of Pulmonary Infection and Respiratory Insufficiency, run by Wuerzburg University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Perioperative pulmonary function tests
How many people
31 participants
Where
1 siteGermany
Study dates
Jun 2016to Aug 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: adult inpatients undergoing elective surgery

Who may be able to join

  • Adult
  • Inpatient
  • Lung surgery under general anaesthesia

Who cannot join

  • Missing informed consent
  • Outpatient
  • Emergency procedure
  • Revision surgery of hospitalized patients
  • Pneumothorax
  • Pleural effusion
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Würzburg

    Würzburg, 97080

Other trials in Germany

About this study

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.

Read the detailed description

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.

Being tested
Perioperative pulmonary function tests
Medical subject headings
Respiratory Insufficiency, Pneumonia, Aspiration, Bronchial Spasm, Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perioperative pulmonary function testsOther

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

Study groups in NCT02779595
Study groupRoleWhat they receive
Lung surgery26 patients (up to 36) undergoing lung surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests
Receives: Other: Perioperative pulmonary function tests
Flail chest8 patients undergoing an operative stabilization of a flail chest will be examined by perioperative pulmonary function tests
Receives: Other: Perioperative pulmonary function tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline and 3. postoperative day

Secondary outcomes (1)

  1. 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

    Measured: baseline and 3. postoperative day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779595
Sponsor's protocol ID
thoraxEIT
Status last verified
Nov 2017
First submitted
17 May 2016
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21045639

  • 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.

    PubMed 24901240

  • 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.

    PubMed 8942326

  • 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.

    PubMed 20963310

  • 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.

    PubMed 23074580

  • 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.

    PubMed 22992946

  • 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.

    PubMed 22531334

  • 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.

    PubMed 23877309

  • 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.

    PubMed 9689281

  • 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.

    PubMed 21261780

  • 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.

    PubMed 25398109

  • 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.

    PubMed 18431279

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Infection and Respiratory Insufficiency, run by Wuerzburg University Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lateral Change from baseline in regional ventilation (time frame: baseline and 3. postoperative day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02779595, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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