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

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ClinicalTrials.gov Identifier: NCT04369027
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hamzaoui Olfa, Hopital Antoine Beclere

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


Condition or disease Intervention/treatment
Hemodynamic Monitoring 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.

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : January 6, 2019
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : May 20, 2020

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 Name: tidal volume challenge

preload unresponders
patients who do not increase their delta VTI by more than 10% during PLR



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


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369027


Locations
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France
Hamzaoui Olfa Recruiting
Clamart, France, 92141
Contact: OLFA HAMZAOUI, MD    0033145374957    olfa.hamzaoui@abc.aphp.fr   
Sponsors and Collaborators
Hopital Antoine Beclere
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Responsible Party: Hamzaoui Olfa, PRINCIPAL INVESTIGATOR, Hopital Antoine Beclere
ClinicalTrials.gov Identifier: NCT04369027    
Other Study ID Numbers: 2018-A00727-48
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes