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Completed

NCT Number: NCT02779595

Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perioperative pulmonary function tests

Other

Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the the third, fifth and seventh postoperative day

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Impact on flail chest surgery to change from baseline in regional ventilation

    Time frame: baseline, 3., 5. and 7. postoperative day

    Measured by EIT

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 20, 2016
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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