Clinical trial NCT02779595: Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery
Official title: Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Infection
Respiratory Insufficiency
Aspiration Pneumonitis
Bronchospasm
Atelectasis
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult inpatients undergoing elective surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lateral Change from baseline in regional ventilation
timeFrame: baseline and 3. postoperative day
Secondary outcomes:
measure: Lateral Change from baseline in regional ventilation depending on side of surgery
timeFrame: baseline and 3. postoperative day
Other outcomes:
measure: Association between lateral change of regional ventilation and change of forced vital capacity
timeFrame: baseline, 3., 5. and 7. postoperative day
measure: Sagittal change from baseline in regional ventilation
timeFrame: baseline, 3., 5. and 7. postoperative day
measure: Association between sagittal change of regional ventilation and change of forced vital capacity
timeFrame: baseline, 3., 5. and 7. postoperative day
measure: Time shift in regional ventilation between ipsi- and contralateral lung
timeFrame: baseline, 3., 5. and 7. postoperative day
measure: Impact on flail chest surgery to change from baseline in regional ventilation
timeFrame: baseline, 3., 5. and 7. postoperative day
Locations:
city: Würzburg
country: Germany
facility: University of Würzburg
Study officials:
affiliation: University of Würzburg, Department of Anaesthesia and Critical Care
name: Markus Kredel, PD.Dr.med
role: PRINCIPAL_INVESTIGATOR
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