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

NCT04369027 | Unknown

• 1 other identifier: 2018-A00727-48
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• predictive capacity of changes of PPV during ppassive leg raising test

  duration of the tests: 15 minutes

Study Arms (2)

preload responders

patients who increase their delta VTI by more than 10% during PLR

Diagnostic Test: passive leg raising

preload unresponders

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

Interventions

passive leg raising DIAGNOSTIC_TEST

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

Also known as: tidal volume challenge

preload responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hopital Antoine Beclere: lead

Study Sites (1)

Hamzaoui Olfa

Clamart, 92141, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 36116288 DERIVED

• 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.

  PMID: 34246460 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: January 6, 2019
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

FR (1)