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Could the Stroke Volume Variation Predict a Fluid Responsiveness in Thoracotomy?

6. oktober 2016 oppdatert av: Hyun Joo Ahn, Samsung Medical Center
There are some risks of pulmonary edema in patients undergoing pulmonary lobectomy with one lung ventilation. The overloading of fluid administration could be related to the development of pulmonary edema in patents after thoracic surgery. But fluid restriction may cause major organ hypoperfusion during the surgery. The purpose of this study is to evaluate the ability of stroke volume variation as an indicator for a fluid responsiveness in patient who receives pulmonary lobectomy via thoracotomy.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Perioperative fluid management during thoracic surgery is a significantly important, because it is quite difficult to prevent pulmonary edema due to the fluid overload and compromise perfusion of vital organ. So, it is essential to maintain optimal organ perfusion by appropriate fluid management during thoracic surgery. Stroke volume variation (SVV) is derived from pulse contour analysis and it is known that SVV ≥12~15% correlate with fluid responsiveness, defined as a significant increase in cardiac output with fluid loading, dung two-lung ventilation. It is a parameter derived from changes in stroke volume (SV) that is according to the heart-lung interaction during mechanical ventilation. positive pressure ventilation induces cyclic changes in left ventricular SV that are related mainly to the expiratory decrease in right ventricular filling and ejection. This is a reflected by variations in the SV. However both ventilator issues, such as tidal volume, PEEP, chest and lung condition, and the cardiovascular condition, such as heart rate, rhythm, ventricular function, cardiac afterload, arterial compliance may affect SVV. Recently some studies reported that SVV could predict fluid responsiveness in mechanically ventilated patients under various conditions. But it is still unclear whether SVV could predict fluid responsiveness during one lung ventilation with the chest open via a thoracotomy. During one-lung ventilation, the shunted blood flow through the non-ventilated-lung dose not contribute to the generation of SVV. And with the chest opening by thoracotomy, the pressure generated by ventilator would not be transmitted to the pulmonary vessels but rather to the atmosphere. So, the purpose of this study is to evaluate the ability of SVV as an indicator a fluid responsiveness particularly in patients undergoing one-lung ventilation with thoracotomy and to found the optimal threshold value of SVV for fluid management during thoracic surgery.

Studietype

Observasjonsmessig

Registrering (Faktiske)

79

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The patients scheduled for pulmonary lobectomy with one lung ventilation by lung cancer, nodule, or pulmonary tuberculosis under thoracoscopy or thoracotomy in our hospital were included.

Beskrivelse

Inclusion Criteria:

  • The patients scheduled for pulmonary lobectomy with one lung ventilation by lung cancer, nodule, or pulmonary tuberculosis under thoracoscopy or thoracotomy in our hospital

Exclusion Criteria:

  • The patients with known cardiac disease include arrythmia
  • American society of anesthesia physical status III, IV, V

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
thoracoscopic pulmonary lobectomy
to observe a fluid responsiveness in patients who receives scheduled thoracoscopic pulmonary lobectomy
Annen: fluid loading

Fluid loading at defined period

  • 500ml colloid solution infusion at 20min after thorax open for 30min. 500ml colloid administration is a kind of routine procedure during pulmonary lobectomy in our hospital. We just control the fluid loading timing for hemodynamic parameter records.
Fremgangsmåte: thoracoscopic pulmonary lobectomy
the patient group for scheduled thoracoscopic pulmonary lobectomy
open pulmonary lobectomy(thoracotomy)
to observe a fluid responsiveness in patients who receives scheduled open pulmonary lobectomy(thoracotomy)
Annen: fluid loading

Fluid loading at defined period

  • 500ml colloid solution infusion at 20min after thorax open for 30min. 500ml colloid administration is a kind of routine procedure during pulmonary lobectomy in our hospital. We just control the fluid loading timing for hemodynamic parameter records.
Fremgangsmåte: thoracotomy
the patient group for scheduled open pulmonary lobectomy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes from baseline in SVV, SVI after fluid loading
Tidsramme: 20min after thorax open and immediate after fluid loading for 30min
we are going to measure the SVV, SVI before and after fluid loading. Fluid responders were defined as patients demonstrating an increase in SVI ≥ 10% and non-responders as patients whose SVI changed < 10%. Receiver operating characteristic (ROC) curves were generated for SVV of each group (responders and non responders). Threshold value of SVV was determined by considering values that yielded the greatest sensitivity and specificity from ROC curve
20min after thorax open and immediate after fluid loading for 30min

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants with Adverse Events (pulmonary complication)
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 1 week
after surgery check chest x-ray It's the routine follow up after lobectomy.
participants will be followed for the duration of hospital stay, an expected average of 1 week
Number of Participants with Adverse Events (compromise perfusion of vital organ )
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 1 week
check perioperative urine output, and check post op serum creatine
participants will be followed for the duration of hospital stay, an expected average of 1 week

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samsung Medical Center

Etterforskere

  • Hovedetterforsker: Hyun Joo Ahn, Samsung Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2014

Primær fullføring (Faktiske)

1. juni 2015

Studiet fullført (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først innsendt

15. desember 2014

Først innsendt som oppfylte QC-kriteriene

1. januar 2015

Først lagt ut (Anslag)

5. januar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. oktober 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. oktober 2016

Sist bekreftet

1. oktober 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2014-06-053-002

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