End-expiratory Occlusion Test and Prediction of Preload Dependence

NCT ID: NCT05874531

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2023-09-15

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.

Conditions

Intensive Care Units; Ultrasonography; Blood Volume

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Responders to fluid challenge

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

End-expiratory occlusion test

Intervention Type: DIAGNOSTIC_TEST

15 seconds end-expiratory occlusion

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.

End-expiratory occlusion test

Intervention Type: DIAGNOSTIC_TEST

15 seconds end-expiratory occlusion

Interventions

End-expiratory occlusion test

15 seconds end-expiratory occlusion

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mongi Slim Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mhamed Sami Mebazaa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mhamed Sami MS Mebazaa, Pr

Role: PRINCIPAL_INVESTIGATOR

Mongi Slim Hospital

Locations

Mongi Slim hospital

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

TOTE Rea

Identifier Type: -

Identifier Source: org_study_id