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Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery

Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02779595
Enrollment
31
Registered
2016-05-20
Start date
2016-06-30
Completion date
2017-08-31
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration Pneumonitis, Atelectasis, Bronchospasm, Pulmonary Infection, Respiratory Insufficiency

Brief summary

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.

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.

Interventions

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

Sponsors

Wuerzburg University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lateral Change from baseline in regional ventilationbaseline and 3. postoperative dayRegional ventilation is measured by pulmonary electrical impedance tomography. The ipsi- and contralateral change in the calculated 'Center of Ventilation' is evaluated

Secondary

MeasureTime frameDescription
Lateral Change from baseline in regional ventilation depending on side of surgerybaseline and 3. postoperative dayRegional 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

MeasureTime frameDescription
Association between sagittal change of regional ventilation and change of forced vital capacitybaseline, 3., 5. and 7. postoperative dayCorrelation testing is done sagittal change in the calculated 'Center of Ventilation' and the forced vital capacity in % of normal (FVC%) by spirometry
Association between lateral change of regional ventilation and change of forced vital capacitybaseline, 3., 5. and 7. postoperative dayCorrelation 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
Impact on flail chest surgery to change from baseline in regional ventilationbaseline, 3., 5. and 7. postoperative dayMeasured by EIT
Time shift in regional ventilation between ipsi- and contralateral lungbaseline, 3., 5. and 7. postoperative dayRegional ventilation is measured by pulmonary electrical impedance tomography. The shift in time of occurence of ipsi- and contralateral Ventilation is evaluated
Sagittal change from baseline in regional ventilationbaseline, 3., 5. and 7. postoperative dayRegional ventilation is measured by pulmonary electrical impedance tomography. The sagittal change in the calculated 'Center of Ventilation' is evaluated

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026