- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03452046
Inferior Vena Cava Indexes in Positive Pressure Supports
Inferior Vena Cava Indexes (Collapsibility, Distensibility, Delta) in Positive Pressure Supports and Prediction Ability of Intravascular Volume Status in ICU Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
The IVC diameters at different pressure supports were measured by the same clinician after obtaining a clear image of where the US and IVC measurements were made and the probe stabilization was achieved. He performed the procedure of changing the pressure supports, a blind independent intensive care physician without working, and recorded the applied pressure supports respectively. The different pressure supports applied are as follows:
- PS 10 mmHg-PEEP 5 mmHg,
- PS 0 mmHg- PEEP 5 mmHg
- PS 10 mmHg- PEEP 0 mmHg.
- T-tube (PS 0 mmHg-PEEP 0 mmHg)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Konak
-
Izmir, Konak, Turkey, 35110
- Tepecik Research and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age>18 years
- Current use of mechanical ventilation through an endotracheal tube.
Exclusion Criteria:
- Profound Hypoxia defined as a fraction of inspired oxygen requirement >90% or a PEEP >10 mmHg
- Patient-ventilator desynchrony or active agitation
- Unstable O2 requirement
- Cardiovascular instability
- Current PEEP requirements of >10 mmHg
- Current oxygen saturation (SpO2) of <88%.
- High intra abdominal pressure
- Right cardiac failure
- Morbid obesity
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PS 10 mmHg, PEEP 5 mmHg
IVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound.
Central venous pressure correlation with IVC index
|
Other Names:
|
PS 10 mmHg PEEP 0 mmHg
IVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound.
Central venous pressure correlation with IVC index
|
Other Names:
|
PS 0 mmHg PEEP 5 mmHg
IVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound.
Central venous pressure correlation with IVC index
|
Other Names:
|
t tube (PS 0 mmHg PEEP 0mmHg)
IVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound.
Central venous pressure correlation with IVC index
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the effect of positive pressure on IVC collapsibility index
Time Frame: 12 month
|
Determine the effect on CI-IVC of an increase in positive end-expiratory pressure and pressure support
|
12 month
|
Determine the effect of positive pressure on IVC distensibility index
Time Frame: 12 month
|
Determine the effect on distensibility index of an increase in positive end-expiratory pressure and pressure support
|
12 month
|
Determine the effect of positive pressure on IVC delta index
Time Frame: 12 month
|
Determine the effect on delta index of an increase in positive end-expiratory pressure and pressure support
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the effect of positive pressure on central venous pressure
Time Frame: 12 month
|
Determine the effect on central venous pressure of an increase in positive end-expiratory pressure and pressure support
|
12 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tepecik Training and Research Hospital, Tepecik Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tepecik
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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