End-expiratory Occlusion Test and Prediction of Preload Dependence

Sponsor
Mongi Slim Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05874531
Collaborator
(none)
60
1
10.9
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: End-expiratory occlusion test

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
End-expiratory Occlusion Test and Prediction of Preload Dependence: Echocardiographic and Hemodynamic Study in the ICU.
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Jul 31, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mongi Slim hospital Tunis Tunisia 2085

Sponsors and Collaborators

  • Mongi Slim Hospital

Investigators

  • Principal Investigator: Mhamed Sami MS Mebazaa, Pr, Mongi Slim Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mhamed Sami Mebazaa, Professor, Mongi Slim Hospital
ClinicalTrials.gov Identifier:
NCT05874531
Other Study ID Numbers:
  • TOTE Rea
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 25, 2023