Changes of Pulse Pressure Variation Duing Tidal Volume Challenge in Patients With Spontaneous Breathing

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

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

Study Overview

• Status: Unknown
• Conditions: Hemodynamic Monitoring
• Intervention / Treatment: Diagnostic test: passive leg raising

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.

• Study Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92141
    • Recruiting
    • Hamzaoui Olfa
    • Contact: OLFA HAMZAOUI, MD; Phone Number: 0033145374957; Email: olfa.hamzaoui@abc.aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
preload responders; patients who increase their delta VTI by more than 10% during PLR	Diagnostic test: passive leg raising; passive leg raising: to raise the legs of the patients by adjusting the angle of the patient's bed during one minute. Tidal volume challenge: an increas by 2ml/Kg of the tidal volume during one minute; Other Names: tidal volume challenge
preload unresponders; patients who do not increase their delta VTI by more than 10% during PLR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predictive capacity of the changes of PPV during tidal volume challenge	A roc curve analysis will be performed in order to determine the specificity and the sensitivity of this test to predict preload responsiveness	duration of the tests: 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predictive capacity of changes of PPV during ppassive leg raising test	A roc curve analysis will be erformed in order to determine the specificity and the sensitivity of this test to predict preload responsiveness	duration of the tests: 15 minutes

Collaborators and Investigators

• Sponsor: Hopital Antoine Beclere

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2019
• Primary Completion (Anticipated): May 20, 2020
• Study Completion (Anticipated): May 20, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018-A00727-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No