Clinical trial NCT04369027: Changes of Pulse Pressure Variation Duing Tidal Volume Challenge in Patients With Spontaneous Breathing
Official title: Can Dynamic Changes of Pulse Pressure Variation During Passive Leg Raising or a Tidal Volume Challenge Help Predicting Preload Responsiveness in Mechanically Ventilated Patients With Spontaneous Breathing Activity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodynamic Monitoring
Lead sponsor: Hopital Antoine Beclere
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under mechanical ventilation with spontaneous cycles, for whom the physician in charge decided to test preload responsiveness were included with because of mean arterial pressure (MAP) \< 65 mmHg (measured by an arterial catheter) or other symptoms of acute circulatory failure (e.g. oliguria, skin mottling, tachycardia, hyperlactatemia)

Brief summary: Background: Predicting preload responsiveness by using dynamic indicators before administering fluids to critically ill patients is nowadays routinely performed at the bedside. Unlike other dynamic indicators of preload responsiveness that require cardiac output monitoring, pulse pressure variation (PPV) can be simply obtained via an arterial catheter . However, PPV is not reliable in mechanically ventilated patients with spontaneous breathing activity. We hypothesized that an increase in PPV after a tidal volume (TV) challenge (TVC) or a decrease in PPV during passive leg raising (PLR) will predict preload responsiveness in such cases.

Objective: to examine if the change in PPV during PLR and after a TVC can predict preload responsiveness in patients with mechanical ventilation and persistent spontaneous breathing

Detailed description: Prospective non interventional study conducted in two intensive care units. Patients under mechanical ventilation with spontaneous cycles, for whom the physician in charge decided to test preload responsiveness were included. We collected demographic and clinical information, the use of mechanical ventilation and its parameters, the use of vasopressors and their dosage and blood lactate.

Firstly, transthoracic echocardiography (TTE) was performed to measure the velocity time integral (VTI) of the left ventricular outflow tract .

A PLR maneuvre is performed with TTE probe in place and a new assessement of VTI is measured, in addition to the PPV and other hemodynamic parmeters (Diastolic, mean and systolic arterial pressure, heart rate, CVP). Delta VTI is the difference between VTI during PLR and VTI at baseline divided by VTI at baseline.

Patients were considered as preload responsive when delta VTI was ≥10%. Secondly, a TVC was performed by increasing the TV by 2mL/kg predicted body weight from its baseline value . PPV was recorded before and after the TVC in addition to the other hemodynamic parmeters listed above. Further more, respiratory parameters are collected: ventilator setting, plateau pressure, upper airway pressure, before and during the TVC.

Eligibility criteria: Inclusion Criteria:

* adult critically ill patients if the clinicians in charge decided to test preload responsiveness because of mean arterial pressure (MAP) \< 65 mmHg (measured by an arterial catheter) or other symptoms of acute circulatory failure (e.g. oliguria, skin mottling, tachycardia, hyperlactatemia)

Exclusion Criteria:

* Arrythmia
* no spontaneous breathing
* difficult condition for tansthoracic echocardiography

Primary outcomes:
measure: predictive capacity of the changes of PPV during tidal volume challenge
timeFrame: duration of the tests: 15 minutes
Secondary outcomes:
measure: predictive capacity of changes of PPV during ppassive leg raising test
timeFrame: duration of the tests: 15 minutes
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hamzaoui Olfa
Study officials:
References:
citation: Shi R, Moretto F, Prat D, Jacobs F, Teboul JL, Hamzaoui O. Dynamic changes of pulse pressure but not of pulse pressure variation during passive leg raising predict preload responsiveness in critically ill patients with spontaneous breathing activity. J Crit Care. 2022 Dec;72:154141. doi: 10.1016/j.jcrc.2022.154141. Epub 2022 Sep 15.
citation: Hamzaoui O, Shi R, Carelli S, Sztrymf B, Prat D, Jacobs F, Monnet X, Gouezel C, Teboul JL. Changes in pulse pressure variation to assess preload responsiveness in mechanically ventilated patients with spontaneous breathing activity: an observational study. Br J Anaesth. 2021 Oct;127(4):532-538. doi: 10.1016/j.bja.2021.05.034. Epub 2021 Jul 8.