End-expiratory Occlusion Test and Prediction of Preload Dependence

NCT05874531 | Completed

• 1 other identifier: TOTE Rea
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Units; Ultrasonography; Blood Volume

Outcome Measures

Primary Outcomes (1)

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

  the variation of sub aortic VTI by cardiac ultrasonography

  before and 10 minutes after 250 mL saline administration

Study Arms (2)

Responders to fluid challenge

Responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion.

Diagnostic Test: End-expiratory occlusion test

Non responders to fluid challenge

Non responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion.

Diagnostic Test: End-expiratory occlusion test

Interventions

End-expiratory occlusion test DIAGNOSTIC_TEST

15 seconds end-expiratory occlusion

Non responders to fluid challenge; Responders to fluid challenge

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

Sixty patients were included. The main causes of admission in intensive care were traumatic causes, post operative care or medical causes. 35 were responders avec 25 non responders to fluid load.

You may qualify if:

• 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.

You may not qualify if:

• Pulmonary Edema
• arrythmia
• dialysis
• Prone position

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (1)

Mongi Slim hospital

Tunis, 2085, Tunisia

Location

Study Officials

• Mhamed Sami MS Mebazaa, Pr

  Mongi Slim Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 25, 2023
• Study Start: May 15, 2023
• Primary Completion: August 15, 2023
• Study Completion: September 15, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)