Positive-Pressure RespirationsNCT03452046
Inferior Vena Cava Indexes in Positive Pressure Supports
An observational study of Positive-Pressure Respirations and Respiratory Failure, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Collapsibility (CI-IVC), distensibility (dIVC) and delta (ΔIVC) indices, which are dynamic measures of inferior vena cava (IVC) diameter, are used to assess the intravascular volume status in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positive-Pressure Respirations, Respiratory Failure
- What is being tested?
- IVC diametres
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2016to 15 Mar 2018
- 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: Inpatient sample
Who may be able to join
- Age>18 years
- Current use of mechanical ventilation through an endotracheal tube.
Who cannot join
- 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%.
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- High intra abdominal pressure
- Right cardiac failure
- Morbid obesity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Research and Training Hospital
Izmir, Konak, 35110
About this study
Official title: Inferior Vena Cava Indexes (Collapsibility, Distensibility, Delta) in Positive Pressure Supports and Prediction Ability of Intravascular Volume Status in ICU Patients
Collapsibility (CI-IVC), distensibility (dIVC) and delta (ΔIVC) indices, which are dynamic measures of inferior vena cava (IVC) diameter, are used to assess the intravascular volume status in critically ill patients. Positive pressure support (PS) has been shown to induce IVC diameter distention by increasing intrathoracic pressure, and high positive expiratory pressure (PEEP) decreases the CI-IVC percentage (4). During Triggered positive pressure support it is necessary to clarify which IVC index is valid for measuring the volume status.it is aimed to compare the IVC indexes (CI-IVC, DIVC, ΔIVC), positive rate of change with pressure, correlation with central venous pressure and accurate prediction of volume status in patients with different positive pressure support.
Read the 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)
- Being tested
- IVC diametres
- Keywords
- Ultrasound,inferior vena cava, positive pressure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVC diametresOther
Also called Measurement of central venous pressure, Positive pressure supports
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: IVC diametres | |
| 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 Receives: Other: IVC diametres | |
| 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 Receives: Other: IVC diametres | |
| 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 Receives: Other: IVC diametres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of positive pressure on IVC collapsibility index
Determine the effect on CI-IVC of an increase in positive end-expiratory pressure and pressure support
Measured: 12 month
Determine the effect of positive pressure on IVC distensibility index
Determine the effect on distensibility index of an increase in positive end-expiratory pressure and pressure support
Measured: 12 month
Determine the effect of positive pressure on IVC delta index
Determine the effect on delta index of an increase in positive end-expiratory pressure and pressure support
Measured: 12 month
Secondary outcomes (1)
Determine the effect of positive pressure on central venous pressure
Determine the effect on central venous pressure of an increase in positive end-expiratory pressure and pressure support
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Sep 2016
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive-Pressure RespirationsStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut Saritas, Tepecik Training and Research Hospital
- Investigators
- Tepecik Training and Research Hospital, Principal investigator, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452046
- Sponsor's protocol ID
- Tepecik
- Status last verified
- Apr 2018
- First submitted
- 25 Feb 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Vena Cava Indexes (Collapsibility, Distensibility, Delta) in Positive Pressure Supports and Prediction Ability of Intravascular Volume Status in ICU Patients
- ClinicalTrials.gov ID
- NCT03452046
- Acronym / sponsor ID
- Tepecik
- Keywords
- Ultrasound,inferior vena cava, positive pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 2 Mar 2018 (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.
Collapsibility (CI-IVC), distensibility (dIVC) and delta (ΔIVC) indices, which are dynamic measures of inferior vena cava (IVC) diameter, are used to assess the intravascular volume status in critically ill patients. Positive pressure support (PS) has been shown to induce IVC diameter distention by increasing intrathoracic pressure, and high positive expiratory pressure (PEEP) decreases the CI-IVC percentage (4). During Triggered positive pressure support it is necessary to clarify which IVC index is valid for measuring the volume status.it is aimed to compare the IVC indexes (CI-IVC, DIVC, ΔIVC), positive rate of change with pressure, correlation with central venous pressure and accurate prediction of volume status in patients with different positive pressure support.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PS 10 mmHg, PEEP 5 mmHg | – | Other: IVC diametresIVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound. Central venous pressure correlation with IVC index |
| PS 10 mmHg PEEP 0 mmHg | – | Other: IVC diametresIVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound. Central venous pressure correlation with IVC index |
| PS 0 mmHg PEEP 5 mmHg | – | Other: IVC diametresIVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound. Central venous pressure correlation with IVC index |
| t tube (PS 0 mmHg PEEP 0mmHg) | – | Other: IVC diametresIVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound. Central venous pressure correlation with IVC index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient sample
Key inclusion criteria (2 listed)
- Age>18 years
- Current use of mechanical ventilation through an endotracheal tube.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| IVC diametresAlso: Measurement of central venous pressure, Positive pressure supports | Other | PS 0 mmHg PEEP 5 mmHg, PS 10 mmHg PEEP 0 mmHg, PS 10 mmHg, PEEP 5 mmHg, t tube (PS 0 mmHg PEEP 0mmHg) |
Primary outcome
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
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
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
1 secondary outcome
Determine the effect of positive pressure on central venous pressure
Time frame: 12 month
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 24 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Tepecik Training and Research Hospital principal investigator
Tepecik Training and Research 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 Positive-Pressure Respirations and Respiratory Failure, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 9 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 24 Apr 2018. 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 Turkey (Türkiye). 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?
Determine the effect of positive pressure on IVC collapsibility index (time frame: 12 month). The study lists 3 primary outcomes in all. 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 24 Apr 2018.