Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Perioperative Change of Regional Ventilation During Spontaneous Breathing

29. februar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

72

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Würzburg, Tyskland, 97080
        • University of Würzburg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

adult inpatients undergoing elective surgery

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
abdominal surgery
27 patients undergoing abdominal surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests
Andet: Perioperative pulmonary function tests
Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
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
Andet: Perioperative pulmonary function tests
Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
flail chest
10 patients undergoing an operative stabilization of a flail chest will be examined by perioperative pulmonary function tests
Andet: Perioperative pulmonary function tests
Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in regional ventilation at the first postoperative day
Tidsramme: baseline and 1. 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
Tidsramme: baseline and 3. 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in forced vital capacity (FVC)
Tidsramme: baseline, 1. and 3. postoperative day
Measured by spirometry. The best value of three attempts is used.
baseline, 1. and 3. postoperative day

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in forced expiratory volume in one second (FEV1)
Tidsramme: baseline, 1. and 3. postoperative day
Measured by spirometry. The best value of three attempts is used.
baseline, 1. and 3. postoperative day
Change in peripheral oxygen saturation
Tidsramme: baseline, 1. and 3. postoperative day
Measured by pulse oximetry
baseline, 1. and 3. postoperative day
Change in pain score
Tidsramme: baseline, 1. and 3. postoperative day
Measured by visual analogue scale
baseline, 1. and 3. postoperative day
Change in respiratory rate
Tidsramme: baseline, 1. and 3. postoperative day
Measured by electric impedance tomography
baseline, 1. and 3. postoperative day
pulmonary complications
Tidsramme: baseline, 1., 3. and 7. postoperative day or at discharge
Defined as pulmonary infection, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis or respiratory insufficiency
baseline, 1., 3. and 7. postoperative day or at discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wuerzburg University Hospital

Efterforskere

  • Ledende efterforsker: Markus Kredel, PD. Dr. med, University of Würzburg, Department of Anaesthesia and Critical Care

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2015

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

1. december 2014

Først indsendt, der opfyldte QC-kriterier

13. april 2015

Først opslået (Skøn)

17. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • perioperativeEIT

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pneumothorax

Kliniske forsøg med Perioperative pulmonary function tests

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner