Inferior Vena Cava Indexes in Positive Pressure Supports

Respiratory Failure Clinical Trial

Official title:

Inferior Vena Cava Indexes (Collapsibility, Distensibility, Delta) in Positive Pressure Supports and Prediction Ability of Intravascular Volume Status in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452046
• Other study ID #: Tepecik
• Status: Completed
• First received: February 25, 2018
• Last updated: April 23, 2018
• Start date: September 1, 2016
• Est. completion date: March 15, 2018

Study information

• Verified date: April 2018
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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:

1. PS 10 mmHg-PEEP 5 mmHg,

2. PS 0 mmHg- PEEP 5 mmHg

3. PS 10 mmHg- PEEP 0 mmHg.

4. T-tube (PS 0 mmHg-PEEP 0 mmHg)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 15, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Positive-Pressure Respirations
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• IVC diametres

Locations

Country	Name	City	State
Turkey	Tepecik Research and Training Hospital	Izmir	Konak

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 month
Primary	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	12 month
Primary	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	12 month
Secondary	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	12 month