Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery

November 2, 2017 updated by: Wuerzburg University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

31

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
      • Würzburg, Germany, 97080
        • University of Würzburg

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult inpatients undergoing elective surgery

Description

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

Exclusion criteria during clinical course:

  • performed pneumonectomy
  • Reoperation
  • postoperative ventilation at the third day

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Perioperative pulmonary function tests
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
Other: Perioperative pulmonary function tests
Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the the third, fifth and seventh postoperative day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lateral Change from baseline in regional ventilation
Time Frame: baseline and 3. postoperative day
Regional ventilation is measured by pulmonary electrical impedance tomography. The ipsi- and contralateral change in the calculated 'Center of Ventilation' is evaluated
baseline and 3. postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lateral Change from baseline in regional ventilation depending on side of surgery
Time Frame: baseline and 3. postoperative day
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
baseline and 3. postoperative day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between lateral change of regional ventilation and change of forced vital capacity
Time Frame: baseline, 3., 5. and 7. postoperative day
Correlation testing is done on the ipsi- and contralateral change in the calculated 'Center of Ventilation' and the forced vital capacity in % of normal (FVC%) by spirometry
baseline, 3., 5. and 7. postoperative day
Sagittal change from baseline in regional ventilation
Time Frame: baseline, 3., 5. and 7. postoperative day
Regional ventilation is measured by pulmonary electrical impedance tomography. The sagittal change in the calculated 'Center of Ventilation' is evaluated
baseline, 3., 5. and 7. postoperative day
Association between sagittal change of regional ventilation and change of forced vital capacity
Time Frame: baseline, 3., 5. and 7. postoperative day
Correlation testing is done sagittal change in the calculated 'Center of Ventilation' and the forced vital capacity in % of normal (FVC%) by spirometry
baseline, 3., 5. and 7. postoperative day
Time shift in regional ventilation between ipsi- and contralateral lung
Time Frame: baseline, 3., 5. and 7. postoperative day
Regional ventilation is measured by pulmonary electrical impedance tomography. The shift in time of occurence of ipsi- and contralateral Ventilation is evaluated
baseline, 3., 5. and 7. postoperative day
Impact on flail chest surgery to change from baseline in regional ventilation
Time Frame: baseline, 3., 5. and 7. postoperative day
Measured by EIT
baseline, 3., 5. and 7. postoperative day

Collaborators and Investigators

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

Sponsor

Wuerzburg University Hospital

Investigators

  • Principal Investigator: Markus Kredel, PD.Dr.med, University of Würzburg, Department of Anaesthesia and Critical Care

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 (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (ESTIMATE)

May 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • thoraxEIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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