An observational study in Shock, Septic Shock and Sepsis, sponsored by Bicetre Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-23.
Sponsored by Bicetre Hospital · Observational
The aim of this study is to assess whether changes in the plethysmography variability index, during a tidal volume challenge, can reliably detect simultaneous changes in arterial blood pressure pulsatility, in patients hospitalized in intensive care unit. If results will be positive, this will allow the test to be performed even in the absence of an invasive arterial catheter.
Among patients in a state of shock one of the first treatments is volume expansion, consisting in a fast intravenous injection of crystalloid or colloid solutions in order to increase cardiac preload and consequently cardiac output. However, this augmentation of the cardiac output happens only in half of the patients.To avoid ineffective fluid administration several tests have been developed.
One of these tests is called the "tidal volume challenge" (TVC). It consists of transiently increasing for 1 minute the volume of air inhaled with each breath, in mechanically ventilated patients, and then evaluating whether this change impacts the pulsatility of the arterial blood pressure, detected by an arterial catheter. This test seems reliable, but it requires an arterial catheter to be in place.
It has been suggested in previous studies that pulsatility of blood pressure can be estimated by the pulsatility of the plethysmography signal ("plethysmography variability index"), obtained from the oxygen saturation signal that's measured in all intensive care patients. The advantage is that this measurement only requires a sensor placed at the end of a finger, on the earlobe or on the forehead.
The aim of the study is to assess whether changes in the plethysmography variability index (PVI) during a TVC can reliably detect simultaneous changes in blood pressure pulsatility. This study will include patients hospitalized in intensive care unit, mechanically ventilated, in whom physicians have decided to perform a TVC as common practice. Changes, occurred during this test, in arterial blood pressure pulsatility and in plethysmography pulsatility index will be measured and compared. If results will show that changes in PVI during TVC are reliable for measuring blood pressure pulsatility changes during this test, this will allow the test to be used even in the absence of an arterial catheter.
916 studies on the registry are indexed under Shock; 176 are open to participants now.
This study's planned enrollment of 44 is below the median of 91 across 346 observational studies indexed under Shock.
Browse Shock studies →Bicetre Hospital is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
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Patients hospitalized in intensive care unit, mechanically ventilated with a tidal volume of 6 ml/kg on ideal body weight, with oxygen saturation monitoring with Masimo SET and cardiac output monitoring with PICCO2 system in place.
Exclusion Criteria:
Reliability of PVI changes in diagnosing preload responsiveness during TVC
The primary objective is to assess the reliability of PVI changes induced by a tidal volume challenge test in diagnosing a preload responsiveness state in adult ICU patients.
Time frame: TVC is performed in 1 minute
Reliability of PVI absolute values to diagnose preload responsiveness
Secondary objective is to test the reliability of absolute values of PVI to diagnose a preload responsiveness state in adult intensive care patients.
Time frame: TVC is performed in 1 minute
Evaluation of PVI changes during TVC according to sensor position
Third objective is to compare the value of changes in PVI induced by a tidal volume challenge test to diagnose a preload responsiveness state according to the location of the plethysmographic measurement (finger, earlobe, forehead).
Time frame: TVC is performed in 1 minute
Comparison of PPV and PVI changes during PLR test or volume expansion
Forth objective is to compare the changes in pulse pressure variation (PPV) and PVI during a passive leg raising test (PLR) and a volume expansion, if applicable.
Time frame: PLR is performed in 1 minute
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Bicetre Hospital