PletHysmographic Variation InDex to pRedict Fluid Responsiveness in Spontaneously breAThing patiEnts Treated With High Flow Nasal Cannula
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Best cutoff value of the PVi to identify fluid responsiveness
Study Overview
Brief Summary
The plethysmographic variation index (PVi) is a measure of the respiratory-induced variations in the plethysmographic waveform. Interestingly, in mechanically ventilated patients and under certain conditions, PVi may reflect fluid responsiveness (FR).
Patients treated with high flow nasal cannula (HFNC), which has been described as a useful supportive therapy in spontaneously breathing patients with respiratory failure, may present the same hemodynamic changes, measured by transthoracic echocardiography, as those patients who are mechanically ventilated (MV). The hypothesis of the present study is that the PVi may predict FR in HFNC patients and, therefore, the objective is to investigate whether the PVi can predict FR in patients treated with HFNC.
Detailed Description
STUDY BACKGROUND The plethysmographic variation index (PVi) is a measure of the respiratory-induced variations in the plethysmographic waveform. Interestingly, in mechanically ventilated patients and under certain conditions, PVi may reflect fluid responsiveness (FR) (Loupec T Crit Care Med 2011; Sandroni C Intensive Care Med 2012).
High flow nasal cannula (HFNC) has been described as a useful supportive therapy in spontaneously breathing patients with respiratory failure (Roca Crit Care 2016), by increasing lung volume and generating a certain level of airway positive pressure. It has been shown that patients treated with HFNC may present the same hemodynamic changes, measured by transthoracic echocardiography, as those patients who are mechanically ventilated (MV) (Roca J Crit Care 2013). Therefore, PVi may also be useful in HFNC patients.
HYPOTHESIS AND OBJECTIVE As the hemodynamic changes associated with HFNC use are similar to those observed in MV patients, the hypothesis of the present study is that PVi may predict FR in HFNC patients.
The objective is to investigate whether the PVi can predict FR in patients treated with HFNC.
METHODS
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients treated with HFNC presenting with circulatory insufficiency defined as the presence of any of the folling signs: 1) hypotension (systolic blood pressure <90 mm Hg or the need for norepinephrine), 2) oliguria (urine output <0.5 mL/kg/hr), and 3) cool, mottled extremities.
Exclusion Criteria
- •Cardiac arrhythmia
- •Known intracardiac shunt
- •Severe valvular heart disease
- •Severe hypoxemia (PaO2/FIO2 <60 mmHg)
- •Left ventricular ejection fraction of <50%
- •Hemodynamic instability during the procedure (defined as the variation in heart rate or blood pressure of >10% over the 15-min period before starting the protocol) and those with variations in arterial pulse pressure <13%.
Outcomes
Primary Outcomes
Best cutoff value of the PVi to identify fluid responsiveness
Time Frame: 30 minutes
Best cutoff value of the PVi (defined by the Youden method) for correctly classifying HFNC patients who would respond to fluid challenge (ΔCO \>10%).
Secondary Outcomes
No secondary outcomes reported