End-expiratory Occlusion Test and Prediction of Preload Dependence

NCT05874531 — Completed, 60 participants, Mongi Slim Hospital

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End-expiratory Occlusion Test and Prediction of Preload Dependence: Echocardiographic and Hemodynamic Study in the ICU.

RegistryNCT05874531
StatusCompleted
Study typeObservational
Enrollment60 (Actual)
SponsorMongi Slim Hospital (Other)
ConditionsIntensive Care Units, Ultrasonography, Blood Volume
InterventionsEnd-expiratory occlusion test (Diagnostic test)
Datesstart 2023-05-15, primary completion 2023-08-15, completion 2023-09-15, first posted 2023-05-25, last updated 2023-09-25
Locations1 site in Tunisia

Related Papers Related Patents Related Grants Related Experts
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-Summary

Three sets of measurements of hemodynamic parameters and sub-aortic VTI were performed: before and at the end of 15 seconds end-expiratory occlusion and after 250 mL saline administration over 10 minutes. Patients were considered responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion. SPSS was used for statistic study. A p < 0.05 was considered significant. The investigators performed univariate and then multivariate analysis.

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+Detailed description

The patients included were in the supine position in a prone position at 30°. They had continuous monitoring by: electrocardioscopy; pulse oximetry and invasive blood pressure. Diuresis was monitored hourly.

A venous access to the superior vena cava territory (central venous catheter) was set up.

The patients were sedated with a Ramsay score > 4 and ventilated in controlled assisted mode.

The sub-aortic TVI (in cm) was measured in an apical 5-chamber section by pulsed Doppler using a 1-5 MHz ultrasound probe (M-Turbo sonosite). Three sets of measurements of hemodynamic parameters and sub-aortic VTI were performed: before and at the end of 15 seconds end-expiratory occlusion and after 250 mL saline administration over 10 minutes. At each point, the investigators noted the hemodynamic, ultrasound and biological parameters.

+Arms and interventions

ArmTypeInterventionsDescription
Responders to fluid challengeDiagnostic Test: End-expiratory occlusion testResponders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion.
Non responders to fluid challengeDiagnostic Test: End-expiratory occlusion testNon responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion.
  • End-expiratory occlusion test (Diagnostic test): 15 seconds end-expiratory occlusion

+Outcome measures

Primary outcomes

  • an increase in sub-aortic VTI of more than 10% [before and 10 minutes after 250 mL saline administration]: the variation of sub aortic VTI by cardiac ultrasonography

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients under mechanical ventilation and sedation in the intensive care units
* patients for whom the decision of 250 mL saline administration was taken for : hypotension (systolic pression under 90 mmHg or diatolic pression under 40 mmHg or tachycardia more than 90 pulse per minute or oliguria or the increase in cathecholamin needs.

Exclusion Criteria:

* Pulmonary Edema
* arrythmia
* dialysis
* Prone position

+Locations (1)

FacilityCityCountryStatus
Mongi Slim hospitalTunisTunisia

+Investigators