End-expiratory Occlusion Test and Prediction of Preload Dependence

Completed

• Conditions: Blood Volume; Ultrasonography; Intensive Care Units
• Interventions: Diagnostic Test: End-expiratory occlusion test

• Registration Number: NCT05874531
• Lead Sponsor: Mongi Slim Hospital

Brief 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.

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.

Study Timeline

• Study First Submitted: 2023-04-28
• Study Start: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-25
• Primary Completion: 2023-08-15
• Status Verified: 2023-09
• Study Completion: 2023-09-15
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Responders to fluid challenge	End-expiratory occlusion test	Responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion.
Non responders to fluid challenge	End-expiratory occlusion test	Non responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mongi Slim hospital; 🇹🇳 Tunis, Tunisia