- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02288767
The Effect of Fluid Management by SVV of FloTrac/ Vigileo™ Monitoring on Postoperative Recovery in Bowel Resection
12. september 2017 opdateret af: Yonsei University
During an enterectomy, especially in an open surgery, large amounts of fluid are administered in consideration of the patient's fasted state, maintaining blood pressure during surgery and potential third space loss.
However, it has recently been reported that excessive fluid administration during surgery is actually detrimental to patients' prognoses.
In fact, several reports have suggested that compared to limited fluid administration, excessive fluid administration increased the length of stay or the chances of complications.
Thus, goal-directed fluid optimization is required during surgery because only a proper amount of fluid (neither limited nor excessive) administration can minimize postoperative complications and enhance prognosis.
In general, the amount of fluid administered is determined with regard to the patient's volume status, including a comprehensive assessment of vital signs such as the pulse rate and blood pressure, and urine volume.
However, this method has limitations in that it is an inadequate indicator of the actual intravascular volume of a patient to determine and administer the proper amount of fluid.
Recently, new methods of measuring volume status that are less invasive and more accurate have been introduced.
These methods include stroke volume variation (SVV) that monitors changes in arterial pressure waveform amplitudes with regard to breathing patterns.
This is an effective method of monitoring fluid responsiveness after placing a catheter via a radial artery puncture.
The stroke output is dependent on the preload, afterload, and cardiac contractility.
The cardiac output is determined by multiplying the stroke output and heart rate.
SVV indicates the difference in stroke output within one breathing cycle.
A direct or indirect measurement of stroke output is required, which can be performed by analyzing arterial pressure waveforms via a FloTrac Sensor (Edwards Lifesciences, USA) monitor.
SVV is known to have a high fluid responsiveness even during open surgeries, yet there is practically no research data on its effect in patients' postoperative recovery and prognosis in comparison to the traditional methods of fluid administration.
Therefore, the investigators will apply SVV via a FloTrac/ Vigileo™ monitor on patients undergoing bowel resection to determine whether it better assists proper fluid administration compared to the traditional method of fluid administration by examining the patients' postoperative prognosis such as bowel movement recovery and length of stay.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
62
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Seoul, Korea, Republikken, 120-752
- Yonsei University, College of Medicine, Yonsei Health System, Yonsei Cancer Center
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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
20 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients aged 20 to 70 scheduled to undergo bowel resection open surgery below the ASA class 3
Exclusion Criteria:
- Patients with significant impairments in heart, kidney, and liver functions
- Patients with arrhythmia such as tachycardia and atrial fibrillation or patients on pacemakers
- Patients diagnosed with peripheral arterial disease or are Allen's test positive
- Patients who underwent surgery on the identical surgical area
- Patients with obesity
- Patients with blood coagulation impairments
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Control group
For the traditional method group, crystalloid and colloid (maximum 50 ml/kg) are provided through the traditional method of assessing the blood pressure, heart rate and urine volume.
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Eksperimentel: SVV group
The method of fluid administration to be employed (traditional or SVV via a FloTrac/ EV1000™ monitor) is determined based on the group.
Fluid administration is performed in accordance with the group; in general, about 10 ml/kg/h is administered although it may vary for each patient depending on the preoperative fasting, fluid loss during surgery (evaporation, emanation, urination, surgical area, etc.), and blood loss.
Crystalloid is administered in the SVV-monitored group with a target below SVV 12%, and a 200-300 ml of colloid (maximum 50 ml/kg) is loaded when SVV is above 12%.
If the patient shows hypertension even when SVV is below 12%, a vasoconstrictor should be administered intermittently or consistently.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Recovery of bowel movement - gas passing time after bowel resection
Tidsramme: 24 hous
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To evaluate the difference in bowel movement recovery whether using SVV or not on the fluid management in the patients undergoing open enterectomy, the difference of postoperative gas passing time will be compared.
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24 hous
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
9. marts 2015
Primær færdiggørelse (Faktiske)
15. august 2017
Studieafslutning (Faktiske)
15. august 2017
Datoer for studieregistrering
Først indsendt
3. november 2014
Først indsendt, der opfyldte QC-kriterier
6. november 2014
Først opslået (Skøn)
11. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 4-2014-0730
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 Tarmresektion
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Seoul National University HospitalRekrutteringLARS - Low Anterior Resection SyndromeKorea, Republikken
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Ankara UniversityAarhus University Hospital; Dokuz Eylul University; Lokman Hekim ÜniversitesiAfsluttetLARS - Low Anterior Resection Syndrome
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HEM Pharma Inc.Premier Research Group plcIkke rekrutterer endnuLARS - Low Anterior Resection Syndrome
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Seoul National University HospitalUkendtSund og rask | Kronisk forstoppelse | Constipated Irritable Bowel Syndrome
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KU LeuvenUniversitaire Ziekenhuizen KU LeuvenIkke rekrutterer endnuEndetarmskræft | LARS - Low Anterior Resection Syndrome
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