Intensive Care UnitsNCT05874531
End-expiratory Occlusion Test and Prediction of Preload Dependence
An observational study of Intensive Care Units and Ultrasonography, run by Mongi Slim Hospital at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Units, Ultrasonography, Blood Volume
- What is being tested?
- End-expiratory occlusion test
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 15 May 2023to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pulmonary Edema
- arrythmia
- dialysis
- Prone position
Trial locations and contacts
1 site in 1 country.
About this study
Official title: End-expiratory Occlusion Test and Prediction of Preload Dependence: Echocardiographic and Hemodynamic Study in the ICU.
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.
Read the 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
- Being tested
- End-expiratory occlusion test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-expiratory occlusion testDiagnostic test
15 seconds end-expiratory occlusion
| Study group | Role | What they receive |
|---|---|---|
| Responders to fluid challenge | Responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion. Receives: 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. Receives: Diagnostic Test: End-expiratory occlusion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
an increase in sub-aortic VTI of more than 10%
the variation of sub aortic VTI by cardiac ultrasonography
Measured: before and 10 minutes after 250 mL saline administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start15 May 2023
- Primary completion15 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Mhamed Sami MS Mebazaa, Pr, Principal investigator, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874531
- Sponsor's protocol ID
- TOTE Rea
- Status last verified
- Sep 2023
- First submitted
- 28 Apr 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-expiratory Occlusion Test and Prediction of Preload Dependence: Echocardiographic and Hemodynamic Study in the ICU.
- ClinicalTrials.gov ID
- NCT05874531
- Acronym / sponsor ID
- TOTE Rea
- Conditions
- Intensive Care Units, Ultrasonography, Blood Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders to fluid challenge | – | Diagnostic Test: End-expiratory occlusion testResponders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion. |
| Non responders to fluid challenge | – | Diagnostic Test: End-expiratory occlusion testNon responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Pulmonary Edema
- arrythmia
- dialysis
- Prone position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| End-expiratory occlusion test15 seconds end-expiratory occlusion | Diagnostic test | Non responders to fluid challenge, Responders to fluid challenge |
Primary outcome
an increase in sub-aortic VTI of more than 10%
Time frame: before and 10 minutes after 250 mL saline administration
the variation of sub aortic VTI by cardiac ultrasonography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mhamed Sami MS Mebazaa, Pr principal investigator
Mongi Slim Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Units and Ultrasonography, run by Mongi Slim Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
an increase in sub-aortic VTI of more than 10% (time frame: before and 10 minutes after 250 mL saline administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.