Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery

Completed

• Conditions: Atelectasis; Pulmonary Infection; Respiratory Insufficiency; Aspiration Pneumonitis; Bronchospasm
• Interventions: Other: Perioperative pulmonary function tests

• Registration Number: NCT02779595
• Lead Sponsor: Wuerzburg University Hospital

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.

Study Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-20
• Study Start: 2016-06
• Primary Completion: 2017-06
• Study Completion: 2017-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung surgery	Perioperative pulmonary function tests	26 patients (up to 36) undergoing lung surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests
Flail chest	Perioperative pulmonary function tests	8 patients undergoing an operative stabilization of a flail chest will be examined by perioperative pulmonary function tests

Primary Outcome Measures

Name	Time	Method
Lateral Change from baseline in regional ventilation	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 Outcome Measures

Name	Time	Method
Lateral Change from baseline in regional ventilation depending on side of surgery	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

Trial Locations

Locations (1)

University of Würzburg; 🇩🇪 Würzburg, Germany