Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography

September 27, 2023 updated by: Dr. med. Michael Schuster, Johannes Gutenberg University Mainz

Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography in Intensive Care Patients Undergoing Epigastric Surgery

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.

Study Overview

Status

Completed

Conditions

Detailed Description

  • Study cycle:

    1. Check of criteria of inclusion/exclusion
    2. Informed consent
    3. Recording preoperative data via paper case report form
    4. Preoperative EIT measurement
    5. Postoperative EIT measurement

    6. Recording postoperative data via paper case report form

      Patients therapy and any diagnostic investigation during hospital stay (apart from EIT measurement) are performed appropriate to patients individual clinical needs and are independent from participation in this clinical trial. As PPC may result from surgical complications (e.g. intra- /postoperative bleeding, anastomotic leak, infection of the wound, injury of neighboring organs) they are monitored.

  • Statistical analysis:

Sample size:

After consultation of Johannes-Gutenberg-University Institute of Medical Biometry and Epidemiology the following procedure was developed: Pre-analysis with 20 patients, then determination of definitive sample size (advised 80 patients).

Population:

Any registered patient is included in population even if no study-treatment was performed. To fulfill Pre-Protocol-Population-criteria EIT-measurement has to be performed before and after elective epigastric surgery and information about PPC must be revealable from patients medical file/records.

  • Analysis of efficacy:

    1. Primary objective:

      (A) Incidence of any PPC (postoperative pulmonary complication) until postoperative day 7; Acquisition of PPC might require diagnostic investigation during hospital stay; investigations are only performed appropriate to patients individual clinical needs. As PPC are defined:

      • I: desaturation, increased oxygen demand (data from electronic health record)
      • II: dys-/atelectasis, pleural effusion, pneumothorax, pulmonary vein congestion (data from thoracic x-ray)
      • III: detected respiratory infection/pneumonia, pulmonary edema, Aspiration, non-invasive/CPAP-Ventilation, necessity of pleural drain/of bronchoscopy (data from electronic health record, x-ray)
      • IV: Reintubation (data from electronic health record), ARDS (according to Berlin Definition)

      (B) regional Distribution of Ventilation (Analysis of EIT raw data pre- and postoperative in 4 regions of interest: ventral, mid-ventral, mid-dorsal, dorsal; correlation between PPC and difference in regional Distribution of Ventilation at defined moment)

    2. Secondary objective: post-hoc Analysis (see down Secondary Outcome Measure)

      Average, Median, Quartile, Standard Deviation are detected and shown in Box-plots (type of graphic). Explorative comparison of parameters is effected by t-Test, Mann-Whitney-U-Test, Fisher-Test dependent on normal distribution.

  • Quality assurance and data management Design, execution and analyzation of the study is ICH-GCP-conform (Good-Clinical-Practice-Guideline of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). All responsible persons are obliged to good clinical practice. All changes in study protocol are to be authorized by responsible Ethics Committee. The P.I. is responsible for source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).

Prior to written informed consent all patients are to be informed about character and consequences of the study. With their signature patients permit collection and use of source data. Every patient receives an Identification code for pseudonymization of data. Analyzation and publication of data is effected anonymously only. Data collection is mainly provided in an electronic data base, besides in a paper-based Case Report Form. All electronic and paper-based data and archived in our Clinical Research Center and are accessible for authorized persons (Monitor, Auditor). The study protocol does not provide audits.

Amendment after Pre-analysis:

We conducted a preliminary study of 23 patients for sample size calculation, aligned with the goal of predicting probability of relevant PPC. Power calculation was based on the assumption that 50 % of patients would develop relevant PPC. We performed a power analysis using the Wilcoxon test. The assumption was that AUC of EIT-parameters for distinguishing PPC-affected patients from non-affected patients would be at least 0.65. In order to demonstrate that AUC is indeed above 0.5, a Wilcoxon test can be applied. AUC=0.65 translates into P(X<Y)=0.65. To demonstrate this at the 5%-significance level with a power of 80%, 116 patients are needed. Considering that approximately 10% of patients may not be evaluable, a total sample size of 130 patients was determined. Interim analysis revealed, that incidence of relevant PPC in the study cohort was lower than assumed in sample size calculation. Therefore a higher sample size was necessary than expected. Furthermore, recruiting was slow. We therefore switched from a confirmatory to a descriptive approach.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland-Pfalz (Rhineland-Palatinate)
      • Mainz, Rheinland-Pfalz (Rhineland-Palatinate), Germany, 55110
        • Universitätsmedizin Mainz, Klinik für Anästhesiologie (University Hospital of Johannes Gutenberg-University Mainz, Department of Anesthesiology)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week
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
1 week
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
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
Time Frame: 1 week
Sensitivity and specifity of postoperative EIT-measure for mortality. Statistical analysis: Sensitivity, Specificity, ROC-curve
1 week
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
1 week
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Marc Bodenstein, marc-bodenstein@gmx.de

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 24, 2014

First Submitted That Met QC Criteria

January 8, 2015

First Posted (Estimated)

January 14, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JohannesGU-EIT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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