NCT02337673

Brief Summary

The purpose of this study is to determine whether Electrical Impedance Tomography can be used as sensitive and specific predictor in the detection of postoperative pulmonary complications (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion, pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia, spasms and obstructions of the airway) in patients undergoing epigastric surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

May 24, 2014

Last Update Submit

September 27, 2023

Conditions

Pulmonary DiseasePostoperative Respiratory ComplicationsMalignant Neoplasm of StomachLiver DiseasesPancreatic Diseases

Keywords

Postoperative Pulmonary ComplicationElectrical Impedance TomographySplenectomyGastric surgeryGastrectomyPancreatic surgeryPancreatectomyLiver surgeryHemihepatectomyCholecystectomyAcute Respiratory Distress SyndromeHypoxemiaAtelectasisPulmonary obstructionPneumoniaPneumothoraxPleural effusionPulmonary edema

Outcome Measures

Primary Outcomes (1)

  • Change of regional ventilation partition (ROI analysis in 8 pulmonary ROIs) from preoperative to postoperative state.

    Comparison of the changed regional ventilation partition to the occurence of postoperative pulmonary complications =\> calculation of sensitivity and specifity of the primary outcome measure to predict PPC. Statistical analysis: receiver operating characteristic (ROC curve).

    1.) First EIT-measure: Preoperative Day; 2.) Second EIT-measure: Day of Operation (after extubation) or in between Postoperative Day 1-7 (in case of deferred extubation)

Secondary Outcomes (6)

  • Postoperative EIT-measured regional ventilation distribution (ROI analysis in 8 pulmonary ROIs)

    1 week

  • Postoperative EIT-measured regional ventilation distribution (ROI analysis in 8 pulmonary ROIs)

    1 week

  • Appearance of all specific forms of PPC (Postoperative Pulmonary Complications) within postoperative day 1-7

    1 week

  • Outcome (e.g. mortality, time of intensive care therapy, ventilator-obligatory-free days on Postoperative Day 1-7 Postoperative EIT-measure is predictive for patients outcome

    1 week

  • Time of intensive care therapy

    1 week

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of a primary care clinic (university hospital) undergoing elective epigastric surgery by laparotomy in general anesthesia with elective postoperative intensive care surveillance.

You may qualify if:

  • age \> 17 years
  • no participation in another trial
  • mental and physical state allow written consent
  • elective epigastric surgery by laparotomy in general anesthesia (e.g. gastrectomy, splenectomy, pancreatic surgery, liver surgery/hemihepatectomy, cholecystectomy)

You may not qualify if:

  • age \< 18 years
  • in women: pregnancy
  • missing or disability for giving written consent
  • emergency patients
  • patients after cardiac surgery less than 3 months ago
  • patients after pulmonary lobectomy during lifetime
  • patients with cardiac stimulator/defibrillator or any other implant with electric activity
  • patients with cutaneous lesions or bandage in the area of EIT electrode placement
  • patients with instability of the spine
  • body mass index \> 50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin Mainz, Klinik für Anästhesiologie (University Hospital of Johannes Gutenberg-University Mainz, Department of Anesthesiology)

Mainz, Rheinland-Pfalz (Rhineland-Palatinate), 55110, Germany

Location

Related Publications (5)

  • Bodenstein M, David M, Markstaller K. Principles of electrical impedance tomography and its clinical application. Crit Care Med. 2009 Feb;37(2):713-24. doi: 10.1097/CCM.0b013e3181958d2f.

    PMID: 19114889BACKGROUND

  • Bodenstein M, Boehme S, Bierschock S, Vogt A, David M, Markstaller K. Determination of respiratory gas flow by electrical impedance tomography in an animal model of mechanical ventilation. BMC Pulm Med. 2014 Apr 29;14:73. doi: 10.1186/1471-2466-14-73.

    PMID: 24779960BACKGROUND

  • Hinz J, Neumann P, Dudykevych T, Andersson LG, Wrigge H, Burchardi H, Hedenstierna G. Regional ventilation by electrical impedance tomography: a comparison with ventilation scintigraphy in pigs. Chest. 2003 Jul;124(1):314-22. doi: 10.1378/chest.124.1.314.

    PMID: 12853539BACKGROUND

  • Richard JC, Pouzot C, Gros A, Tourevieille C, Lebars D, Lavenne F, Frerichs I, Guerin C. Electrical impedance tomography compared to positron emission tomography for the measurement of regional lung ventilation: an experimental study. Crit Care. 2009;13(3):R82. doi: 10.1186/cc7900. Epub 2009 May 29.

    PMID: 19480694BACKGROUND

  • Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.

    PMID: 14693669BACKGROUND

MeSH Terms

Conditions

Lung DiseasesStomach NeoplasmsLiver DiseasesPancreatic DiseasesRespiratory Distress SyndromeHypoxiaPulmonary AtelectasisAirway ObstructionPneumoniaPneumothoraxPleural EffusionPulmonary Edema

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory InsufficiencyRespiratory Tract InfectionsInfectionsPleural Diseases

Study Officials

  • Marc Bodenstein

    marc-bodenstein@gmx.de

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

May 24, 2014

First Posted

January 14, 2015

Study Start

May 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

DE(1)