Tidal Volume Challenge and Lung Recruitment Manoeuvre (TIDALREC): de betrouwbaarheid van polsdrukvariatie of slagvolumevariatie op vloeistofrespons. (TIDALEC)
Intraoperatieve hemodynamische optimalisatie: voorspellende waarde voor vloeistofrespons van de teugvolume-uitdaging en de longrekruteringsmanoeuvre door de variatie van de pulsdruk en de variatie van het systolische ejectievolume te bewaken.
In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's hemodynamic status, it will test two ventilation strategies : the Tidal Volume Challenge (VtC) and the Lung Recruitment Maneuver (LRM).
The objective is to determine whether the variation of 2 parameters such as pulse pression variation (PPV) and stroke volume variation (SVV) during these 2 strategies, allows to predict fluid responsiveness in the operating room for any heavy surgery. All patients will benefit from the 2 ventilation strategies then a fluid administration, called " fluid challenge ", will be performed to discriminate the true responders and others. The order of the ventilation strategies will be determined by randomization.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Lille, Frankrijk, 59037
- Hop Claude Huriez Chu Lille
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients scheduled for major abdominal, vascular or neurosurgery requiring invasive arterial monitoring of SVV and PPV with placement of a radial arterial catheter connected to the ProAQT® System.
- Block duration > 2 hours.
Exclusion Criteria:
- open thoracique surgery
- history of supra ventricular arrhythmias
- beta-blocking patient
- BMI>30 kg.m-2 or <15 kg.min-2
- right ventricular dysfunction
- severe valvulopathies
- intracardiac shunt
- renal failure dialysis
- patient's refusal
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Group 1
Starting LRM (Lung Recruitment Maneuver) |
The LRM is performed first for 30 seconds (an insufflation pressure of 30 cmH2O for 30 seconds is applied). After a free interval of 3 minutes, the VtC is done during 1 minute. For VtC, tidal volume is increased from 6 to 8 ml.kg-1 of predicted body weight. Finally, after a new free interval of 3 minutes, the fluid challenge (consisting in fluid administration of 250 ml of Ringer Lactate) is started for 10 minutes (in aim to determine which patients are responders). This sequence is repeated every 30 minutes (maximum four times). |
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Experimenteel: Group 2
Starting VtC (Tidal Volume Challenge) |
The VtC is performed first for 1 minute. After a free interval of 3 minutes, the LRM is done for 30 seconds. Finally, after another free interval of 3 minutes, the fluid challenge is started for 10 minutes. This sequence is repe-tead every 30 minutes (maximum four times). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Het gebied onder de ROC-curve (AUC) van de variatie van de gepulseerde druk (VPP) tijdens de tidal volume challenge (VtC).
Tijdsspanne: gedurende de hele operatie (gemiddelde duur tussen 3 en 5 uur). Metingen uitgevoerd tijdens reeksen van 30 minuten die tijdens de operatie meerdere keren kunnen voorkomen
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gedurende de hele operatie (gemiddelde duur tussen 3 en 5 uur). Metingen uitgevoerd tijdens reeksen van 30 minuten die tijdens de operatie meerdere keren kunnen voorkomen
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The area under the ROC (AUC) curve of VPP during the alveolar recruit-ment maneuver.
Tijdsspanne: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The AUCs of the two techniques calculated above.
Tijdsspanne: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The area under the ROC curve (AUC) of stroke volume variation (SVV) during the tidal volume challenge (VtC).
Tijdsspanne: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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The area under the ROC curve (AUC) of stroke volume variation (SVV) during the lung recruitment maneuver.
Tijdsspanne: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
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Number of complications in pneumothorax
Tijdsspanne: 1 day (at recovery room after surgery) and at day 2
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Pneumothorax is detected on chest x-ray in recovery room and then on clinical examination at Day 2. |
1 day (at recovery room after surgery) and at day 2
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gilles Lebuffe, MD,PhD, University Hospital, Lille
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
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Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2019_71
- 2020-A01460-39 (Andere identificatie: ID-RCB number,ANSM)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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