Fluid ResponsivenessNCT06254456
Fluid Responsiveness in Prone Patients
A study testing End expiratory occlusion test in people with Fluid Responsiveness, run by Bhumibol Adulyadej Hospital.
Trial summary
To assess fluid responsiveness in prone patient Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- End expiratory occlusion test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 4 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- patients planed to prone position for treatment
Who cannot join
- no consent
- arrhythmia
- pregnancy
- pre existing pneumothorax
- pre existing fluid overload
- cannot insert arterial or central venous catheters
About this study
Official title: End Expiratory Occlusion Test and Tidal Volume Challenge Test for Assess Fluid Responsiveness in Prone Patients
To assess fluid responsiveness in prone patient
- Conditions
- Fluid Responsiveness
- Being tested
- End expiratory occlusion test
- Keywords
- Fluid responsiveness, prone, EEOT, TVC, ARDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End expiratory occlusion testDiagnostic test
Also called Tidal volume challenges test
Fluid responsiveness test
| Study group | Role | What they receive |
|---|---|---|
| Prone patients | Experimental | Not described Receives: Diagnostic Test: End expiratory occlusion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Pressure Variation
Detect the pulse pressure variation from cardiac output monitoring ( A- line )
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion4 May 2025 (estimated)
- Study completion4 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bhumibol Adulyadej Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanadate Sirithanasarn, Bhumibol Adulyadej Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254456
- Sponsor's protocol ID
- 95/66
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End Expiratory Occlusion Test and Tidal Volume Challenge Test for Assess Fluid Responsiveness in Prone Patients
- ClinicalTrials.gov ID
- NCT06254456
- Acronym / sponsor ID
- 95/66
- Conditions
- Fluid Responsiveness
- Keywords
- Fluid responsiveness, prone, EEOT, TVC, ARDS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Bhumibol Adulyadej HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 4 May 2025 (estimated)
- Study completion
- 4 Jul 2028 (estimated)
- First posted
- 12 Feb 2024 (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.
To assess fluid responsiveness in prone patient
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prone patients | Experimental | Diagnostic Test: End expiratory occlusion test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients planed to prone position for treatment
Key exclusion criteria (6 listed)
- no consent
- arrhythmia
- pregnancy
- pre existing pneumothorax
- pre existing fluid overload
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 testAlso: Tidal volume challenges testFluid responsiveness test | Diagnostic test | Prone patients |
Primary outcome
Pulse Pressure Variation
Time frame: 1 year
Detect the pulse pressure variation from cardiac output monitoring ( A- line )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
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This Study Compares Two Noninvasive Dynamic Tools: Lung Ultrasound and Transthoracic Echocardiography Using LVOT VTI. It Aims to Measure the Sensitivity and Specificity of LUS in Guiding Fluid Resuscitation and Early Detection of Fluid Responsiveness and to Prevent Volume Overload
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing End expiratory occlusion test in people with Fluid Responsiveness, run by Bhumibol Adulyadej Hospital.
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Pulse Pressure Variation (time frame: 1 year). 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 12 Feb 2024.