Perioperative Change of Regional Ventilation During Spontaneous Breathing
29 février 2016 mis à jour par: Wuerzburg University Hospital
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
72
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Würzburg, Allemagne, 97080
- University of Würzburg
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
adult inpatients undergoing elective surgery
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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abdominal surgery
27 patients undergoing abdominal surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests
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Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
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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
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Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
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flail chest
10 patients undergoing an operative stabilization of a flail chest will be examined by perioperative pulmonary function tests
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Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change from baseline in regional ventilation at the first postoperative day
Délai: baseline and 1. postoperative day
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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.
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baseline and 1. postoperative day
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Change from baseline in regional ventilation at the third postoperative day
Délai: baseline and 3. postoperative day
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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.
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baseline and 3. postoperative day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in forced vital capacity (FVC)
Délai: baseline, 1. and 3. postoperative day
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Measured by spirometry.
The best value of three attempts is used.
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baseline, 1. and 3. postoperative day
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in forced expiratory volume in one second (FEV1)
Délai: baseline, 1. and 3. postoperative day
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Measured by spirometry.
The best value of three attempts is used.
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baseline, 1. and 3. postoperative day
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Change in peripheral oxygen saturation
Délai: baseline, 1. and 3. postoperative day
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Measured by pulse oximetry
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baseline, 1. and 3. postoperative day
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Change in pain score
Délai: baseline, 1. and 3. postoperative day
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Measured by visual analogue scale
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baseline, 1. and 3. postoperative day
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Change in respiratory rate
Délai: baseline, 1. and 3. postoperative day
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Measured by electric impedance tomography
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baseline, 1. and 3. postoperative day
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pulmonary complications
Délai: baseline, 1., 3. and 7. postoperative day or at discharge
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Defined as pulmonary infection, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis or respiratory insufficiency
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baseline, 1., 3. and 7. postoperative day or at discharge
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Markus Kredel, PD. Dr. med, University of Würzburg, Department of Anaesthesia and Critical Care
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2015
Achèvement primaire (Réel)
1 février 2016
Achèvement de l'étude (Réel)
1 février 2016
Dates d'inscription aux études
Première soumission
1 décembre 2014
Première soumission répondant aux critères de contrôle qualité
13 avril 2015
Première publication (Estimation)
17 avril 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 mars 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 février 2016
Dernière vérification
1 février 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- perioperativeEIT
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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