Perioperative Change of Regional Ventilation During Spontaneous Breathing

NCT02419196 | Completed

• 1 other identifier: perioperativeEIT
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Infection; Pleural Effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration Pneumonitis; Respiratory Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Change in forced vital capacity (FVC)

  baseline, 1. and 3. postoperative day

Other Outcomes (5)

• Change in forced expiratory volume in one second (FEV1)

  baseline, 1. and 3. postoperative day

• Change in peripheral oxygen saturation

  baseline, 1. and 3. postoperative day

• Change in pain score

  baseline, 1. and 3. postoperative day

Study Arms (3)

abdominal surgery

27 patients undergoing abdominal surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests

Other: Perioperative pulmonary function tests

limb surgery

27 patients undergoing upper and lower limb surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests

Other: Perioperative pulmonary function tests

flail chest

10 patients undergoing an operative stabilization of a flail chest will be examined by perioperative pulmonary function tests

Other: Perioperative pulmonary function tests

Interventions

Perioperative pulmonary function tests OTHER

Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day

abdominal surgery; flail chest; limb surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult inpatients undergoing elective surgery

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University of Würzburg

Würzburg, 97080, Germany

Location

Related Publications (10)

• Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate 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.

  PMID: 21045639 BACKGROUND

• Mazo V, Sabate 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.

  PMID: 24901240 BACKGROUND

• 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. doi: 10.1093/bja/77.4.448.

  PMID: 8942326 BACKGROUND

• 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. doi: 10.1590/s0066-782x2010005000137. Epub 2010 Oct 15. English, Portuguese.

  PMID: 20963310 BACKGROUND

• 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.

  PMID: 23074580 BACKGROUND

• 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.

  PMID: 22992946 BACKGROUND

• 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.

  PMID: 22531334 BACKGROUND

• 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.

  PMID: 23877309 BACKGROUND

• 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. doi: 10.1111/j.1399-6576.1998.tb05308.x.

  PMID: 9689281 BACKGROUND

• 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.

  PMID: 31351452 DERIVED

MeSH Terms

Conditions

Pleural Effusion; Pulmonary Atelectasis; Pneumothorax; Bronchial Spasm; Pneumonia, Aspiration; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Pneumonia; Respiratory Tract Infections; Infections; Respiration Disorders

Study Officials

• Markus Kredel, PD. Dr. med

  University of Würzburg, Department of Anaesthesia and Critical Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: April 17, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

DE (1)