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Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02337673
First Posted: January 14, 2015
Last Update Posted: March 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. med. Michael Schuster, Johannes Gutenberg University Mainz
  Purpose
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.

Condition
Pulmonary Disease Postoperative Respiratory Complications Malignant Neoplasm of Stomach Liver Diseases Pancreatic Diseases

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography in Intensive Care Patients Undergoing Epigastric Surgery

Resource links provided by NLM:


Further study details as provided by Dr. med. Michael Schuster, Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Change of regional ventilation partition (ROI analysis in 8 pulmonary ROIs) from preoperative to postoperative state. [ Time Frame: 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) ]
    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).


Secondary Outcome Measures:
  • Postoperative EIT-measured regional ventilation distribution (ROI analysis in 8 pulmonary ROIs) [ Time Frame: 1 week ]

    Sensitivity and specifiy for appearance of PPC (Postoperative Pulmonary Complications) within Postoperative Day 1-7.

    Statistical analysis: Sensitivity, Specificity, ROC-curve


  • Postoperative EIT-measured regional ventilation distribution (ROI analysis in 8 pulmonary ROIs) [ Time Frame: 1 week ]
    Correlation of pre-existing pathologic pulmonary conditions with specific postoperative changes in regional distribution of lung ventilation and perfusion assessed by EIT Statistical analysis: Sensitivity, Specificity, ROC-curve

  • Appearance of all specific forms of PPC (Postoperative Pulmonary Complications) within postoperative day 1-7 [ Time Frame: 1 week ]

    Appearance of all different forms of PPC within Postoperative Day 1-7 and relation to postoperative EIT-measure (ROI analysis in 8 pulmonary ROIs).

    Statistical analysis: Sensitivity, Specificity, ROC-curve


  • 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 [ Time Frame: 1 week ]
    Sensitivity and specifity of postoperative EIT-measure for mortality. Statistical analysis: Sensitivity, Specificity, ROC-curve

  • Time of intensive care therapy [ Time Frame: 1 week ]

    Sensitivity and specifity of postoperative EIT-measure for time of intensive care therapy.

    Statistical analysis: Sensitivity, Specificity, ROC-curve


  • Ventilator-obligatory-free days [ Time Frame: 1 week ]

    Sensitivity and specifity of postoperative EIT-measure for Ventilator-obligatory-free days.

    Statistical analysis: Sensitivity, Specificity, ROC-curve



Enrollment: 130
Study Start Date: May 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337673


Locations
Germany
Universitätsmedizin Mainz, Klinik für Anästhesiologie (University Hospital of Johannes Gutenberg-University Mainz, Department of Anesthesiology)
Mainz, Rheinland-Pfalz (Rhineland-Palatinate), Germany, 55110
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Marc Bodenstein marc-bodenstein@gmx.de
  More Information

Publications:
Responsible Party: Dr. med. Michael Schuster, Dr. med., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02337673     History of Changes
Other Study ID Numbers: JohannesGU-EIT-01
First Submitted: May 24, 2014
First Posted: January 14, 2015
Last Update Posted: March 24, 2016
Last Verified: March 2016

Keywords provided by Dr. med. Michael Schuster, Johannes Gutenberg University Mainz:
Postoperative Pulmonary Complication
Electrical Impedance Tomography
Splenectomy
Gastric surgery
Gastrectomy
Pancreatic surgery
Pancreatectomy
Liver surgery
Hemihepatectomy
Cholecystectomy
Acute Respiratory Distress Syndrome
Hypoxemia
Atelectasis
Pulmonary obstruction
Pneumonia
Pneumothorax
Pleural effusion
Pulmonary edema

Additional relevant MeSH terms:
Lung Diseases
Liver Diseases
Neoplasms
Pancreatic Diseases
Stomach Neoplasms
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Stomach Diseases