Clinical trial NCT02419196: Perioperative Change of Regional Ventilation During Spontaneous Breathing
Official title: Perioperative Change of Regional Ventilation During Spontaneous Breathing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Infection
Pleural Effusion
Atelectasis
Pneumothorax
Bronchospasm
Aspiration Pneumonitis
Respiratory Insufficiency
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 72
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in regional ventilation at the first postoperative day
timeFrame: baseline and 1. postoperative day
measure: Change from baseline in regional ventilation at the third postoperative day
timeFrame: baseline and 3. postoperative day
Secondary outcomes:
measure: Change in forced vital capacity (FVC)
timeFrame: baseline, 1. and 3. postoperative day
Other outcomes:
measure: Change in forced expiratory volume in one second (FEV1)
timeFrame: baseline, 1. and 3. postoperative day
measure: Change in peripheral oxygen saturation
timeFrame: baseline, 1. and 3. postoperative day
measure: Change in pain score
timeFrame: baseline, 1. and 3. postoperative day
measure: Change in respiratory rate
timeFrame: baseline, 1. and 3. postoperative day
measure: pulmonary complications
timeFrame: baseline, 1., 3. and 7. postoperative day or at discharge
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
References:
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citation: Bauer M, Opitz A, Filser J, Jansen H, Meffert RH, Germer CT, Roewer N, Muellenbach RM, Kredel M. Perioperative redistribution of regional ventilation and pulmonary function: a prospective observational study in two cohorts of patients at risk for postoperative pulmonary complications. BMC Anesthesiol. 2019 Jul 27;19(1):132. doi: 10.1186/s12871-019-0805-8.