Perioperative Change of Regional Ventilation During Spontaneous Breathing

Respiratory Insufficiency Clinical Trial

Official title:

Perioperative Change of Regional Ventilation During Spontaneous Breathing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419196
• Other study ID #: perioperativeEIT
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: February 29, 2016
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspiration Pneumonitis
• Atelectasis
• Bronchial Spasm
• Bronchospasm
• Pleural Effusion
• Pneumonia, Aspiration
• Pneumothorax
• Pulmonary Infection
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Other:
• Perioperative pulmonary function tests
Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day

Locations

Country	Name	City	State
Germany	University of Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (9)

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a. — View Citation

Davoudi M, Farhanchi A, Moradi A, Bakhshaei MH, Safarpour G. The Effect of Low Tidal Volume Ventilation during Cardiopulmonary Bypass on Postoperative Pulmonary Function. J Tehran Heart Cent. 2010 Summer;5(3):128-31. Epub 2010 Aug 31. — View Citation

Frerichs I, Hahn G, Golisch W, Kurpitz M, Burchardi H, Hellige G. Monitoring perioperative changes in distribution of pulmonary ventilation by functional electrical impedance tomography. Acta Anaesthesiol Scand. 1998 Jul;42(6):721-6. — View Citation

Guizilini S, Bolzan DW, Faresin SM, Alves FA, Gomes WJ. Ministernotomy in myocardial revascularization preserves postoperative pulmonary function. Arq Bras Cardiol. 2010 Oct;95(5):587-93. Epub 2010 Oct 15. English, Portuguese. — View Citation

Karayiannakis AJ, Makri GG, Mantzioka A, Karousos D, Karatzas G. Postoperative pulmonary function after laparoscopic and open cholecystectomy. Br J Anaesth. 1996 Oct;77(4):448-52. — View Citation

Karsten J, Heinze H, Meier T. Impact of PEEP during laparoscopic surgery on early postoperative ventilation distribution visualized by electrical impedance tomography. Minerva Anestesiol. 2014 Feb;80(2):158-66. Epub 2013 Jul 23. — View Citation

Leonhardt S, Lachmann B. Electrical impedance tomography: the holy grail of ventilation and perfusion monitoring? Intensive Care Med. 2012 Dec;38(12):1917-29. doi: 10.1007/s00134-012-2684-z. Epub 2012 Sep 20. Review. — View Citation

Mazo V, Sabaté S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334. — View Citation

Radke OC, Schneider T, Heller AR, Koch T. Spontaneous breathing during general anesthesia prevents the ventral redistribution of ventilation as detected by electrical impedance tomography: a randomized trial. Anesthesiology. 2012 Jun;116(6):1227-34. doi: 10.1097/ALN.0b013e318256ee08. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in forced expiratory volume in one second (FEV1)	Measured by spirometry. The best value of three attempts is used.	baseline, 1. and 3. postoperative day	No
Other	Change in peripheral oxygen saturation	Measured by pulse oximetry	baseline, 1. and 3. postoperative day	No
Other	Change in pain score	Measured by visual analogue scale	baseline, 1. and 3. postoperative day	No
Other	Change in respiratory rate	Measured by electric impedance tomography	baseline, 1. and 3. postoperative day	No
Other	pulmonary complications	Defined as pulmonary infection, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis or respiratory insufficiency	baseline, 1., 3. and 7. postoperative day or at discharge	No
Primary	Change from baseline in regional ventilation at the first postoperative day	Regional 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.	baseline and 1. postoperative day	No
Primary	Change from baseline in regional ventilation at the third postoperative day	Regional 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.	baseline and 3. postoperative day	No
Secondary	Change in forced vital capacity (FVC)	Measured by spirometry. The best value of three attempts is used.	baseline, 1. and 3. postoperative day	No