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Completed

NCT Number: NCT05874531

End-expiratory Occlusion Test and Prediction of Preload Dependence

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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Key information

Conditions

Intensive Care Units Blood Volume Ultrasonography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mongi Slim hospital

Tunis, 2085, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

End-expiratory occlusion test

Diagnostic Test

15 seconds end-expiratory occlusion

Primary outcomes

  1. an increase in sub-aortic VTI of more than 10%

    Time frame: before and 10 minutes after 250 mL saline administration

    the variation of sub aortic VTI by cardiac ultrasonography

Sponsors and collaborators

Lead sponsor

Mongi Slim Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 25, 2023
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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