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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

Tracking Information
First Submitted Date April 28, 2020
First Posted Date April 30, 2020
Last Update Posted Date May 5, 2020
Actual Study Start Date January 6, 2019
Estimated Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2020)
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
Original Primary Outcome Measures
 (submitted: April 28, 2020)
predictive capacity of the changes of PPV during tidal volume challenge [ Time Frame: duration of the tests: 15 minutes ]
we aimed to draw a roc curve in order to determine the specificity and the sensitivity of this test to predict preload responsiveness
Change History
Current Secondary Outcome Measures
 (submitted: April 30, 2020)
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
Original Secondary Outcome Measures
 (submitted: April 28, 2020)
predictive capacity of changes of PPV during ppassive leg raising test [ Time Frame: duration of the tests: 15 minutes ]
we aimed to draw a roc curve in order to determine the specificity and the sensitivity of this test to predict preload responsiveness
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Hemodynamic Monitoring
Intervention 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
Study Groups/Cohorts
  • preload responders
    patients who increase their delta VTI by more than 10% during PLR
    Intervention: Diagnostic Test: passive leg raising
  • preload unresponders
    patients who do not increase their delta VTI by more than 10% during PLR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 28, 2020)
55
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 20, 2020
Estimated Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04369027
Other Study ID Numbers 2018-A00727-48
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Hamzaoui Olfa, Hopital Antoine Beclere
Study Sponsor Hopital Antoine Beclere
Collaborators Not Provided
Investigators Not Provided
PRS Account Hopital Antoine Beclere
Verification Date May 2020