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Perioperative Change of Regional Ventilation During Spontaneous Breathing

Perioperative Change of Regional Ventilation During Spontaneous Breathing

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02419196
Enrollment
72
Registered
2015-04-17
Start date
2015-01-31
Completion date
2016-02-29
Last updated
2016-03-01

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

Conditions

Aspiration Pneumonitis, Atelectasis, Bronchospasm, Pleural Effusion, Pneumothorax, 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 abdominal and limb operations. In a pilot study arm electrical impedance tomography is tested in patients receiving osteosynthesis of serial rib fractures.

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 abdominal and limb 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. In a group of patients undergoing osteosynthesis of a flail chest, it is tested how regional ventilation changes by these operations and whether pulmonary EIT is actually usable in these patients.

Interventions

Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third 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 * Surgery under general anesthesia with and without additional regional anesthesia * increased risk for postoperative pulmonary complications according to the ARISCAT-Score (except pilot arm for osteosynthesis of flail chest)

Exclusion criteria

* Missing informed consent * Outpatient * Emergency procedure * Revision surgery of hospitalized patients * Operation under local or regional anesthesia alone * Expected postoperative ventilation * 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
Change from baseline in regional ventilation at the first postoperative daybaseline and 1. postoperative dayRegional ventilation is measured by pulmonary electrical impedance tomography. The change in the calculated 'Center of Ventilation' in the sagittal direction is used for the primary outcome measure. Power calculation accounts for the use of two time points for the primary outcome measure.
Change from baseline in regional ventilation at the third postoperative daybaseline and 3. postoperative dayRegional ventilation is measured by pulmonary electrical impedance tomography. The change in the calculated 'Center of Ventilation' in the sagittal direction is used for the primary outcome measure. Power calculation accounts for the use of two time points for the primary outcome measure.

Secondary

MeasureTime frameDescription
Change in forced vital capacity (FVC)baseline, 1. and 3. postoperative dayMeasured by spirometry. The best value of three attempts is used.

Other

MeasureTime frameDescription
Change in respiratory ratebaseline, 1. and 3. postoperative dayMeasured by electric impedance tomography
Change in forced expiratory volume in one second (FEV1)baseline, 1. and 3. postoperative dayMeasured by spirometry. The best value of three attempts is used.
pulmonary complicationsbaseline, 1., 3. and 7. postoperative day or at dischargeDefined as pulmonary infection, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis or respiratory insufficiency
Change in peripheral oxygen saturationbaseline, 1. and 3. postoperative dayMeasured by pulse oximetry
Change in pain scorebaseline, 1. and 3. postoperative dayMeasured by visual analogue scale

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026