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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuerzburg University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • thoraxEIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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