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The effects of hyperoxia on hemodynamics


- candidate number21714
- NTR NumberNTR5064
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-feb-2015
- Secondary IDsP14.046 METC LUMC 
- Public TitleThe effects of hyperoxia on hemodynamics
- Scientific TitleStudy on the effects of hyperoxia on hemodynamic parameters, cerebral perfusion and microcirculation
- ACRONYMOxflow
- hypothesisHypothesis: arterial oxygen concentrations induce dose-dependent hemodynamic and microcirculatory changes during oxygen supply in mechanically ventilated, post cardiac surgery, ICU patients. Aim: In this study we want to investigate the effects of supplemental oxygen on: - dynamic cardiovascular parameters - cerebral perfusion and critical closing pressure - microcirculation
- Healt Condition(s) or Problem(s) studiedIntensive Care (IC) patients, Oxygen concentrations, hyperoxia, Coronary Artery Bypass Grafting (CABG)
- Inclusion criteriaMechanically ventilated adult patients admitted to the ICU after elective coronary bypass grafting surgery
- Exclusion criteriaPregnancy
- Hemodynamic instability with a baseline mean arterial pressure (MAP) < 70 mm Hg, central venous pressure (CVP) >18 mm Hg and / or dependence on moderate to high dosages of inotropic drugs after admittance to the ICU
- Severe arrhythmias
- Intra-cardiac shunts
- Symptomatic peripheral vascular disease
- Symptomatic pulmonary disease
- Clinically significant aortic aneurysm
- Significant valvular regurgitation
- Prior diagnosis of aberrant cardiovascular anatomy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-sep-2014
- planned closingdate20-sep-2015
- Target number of participants22
- InterventionsPrimary:
Increase of supplemental oxygen (FiO2) from baseline level (according to PaO2) to 90%.
Secondary:
- Mandatory inspiratory hold maneuvers.
- Arm occlusion with the Rapid Cuff Inflator by applying pressure above the patientís systolic blood pressure.
- Primary outcomeCardiac output
- Secondary outcomeSystemic blood pressure
Central venous pressure
Heart rate
Cerebral blood flow
Mean systemic filling pressure
Microcirculation
- TimepointsT1 Baseline: PaO2 targeted FiO2 level
T2 Intervention: FiO2 at 90% (15-30 min)
T3 Control: PaO2 targeted FiO2 level
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESH.J.F. M.D. Helmerhorst
- CONTACT for SCIENTIFIC QUERIESH.J.F. M.D. Helmerhorst
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summarySingle-center prospective crossover trial studying the effects of short-term hyperoxia on hemodynamic parameters, cerebral perfusion and microcirculation in mechanically ventilated patients admitted to the ICU after elective coronary bypass grafting surgery
- Main changes (audit trail)
- RECORD23-feb-2015 - 8-jun-2015


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