End-expiratory Occlusion Test and Prediction of Preload Dependence

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05874531
• Other study ID #: TOTE Rea
• Status: Completed
• Start date: May 15, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: Mongi Slim Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Volume
• Intensive Care Units
• Ultrasonography

Intervention

Diagnostic Test:
• End-expiratory occlusion test
15 seconds end-expiratory occlusion

Locations

Country	Name	City	State
Tunisia	Mongi Slim hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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