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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Positive-Pressure Respirations
• Intervention / Treatment: Other: IVC diametres

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:

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)

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Konak
    • Izmir, Konak, Turkey, 35110
      • Tepecik Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inpatient sample

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

Number of groups / cohorts

4

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: IVC diametres; Other Names: Measurement of central venous pressure; Positive pressure supports
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: IVC diametres; Other Names: Measurement of central venous pressure; Positive pressure supports
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: IVC diametres; Other Names: Measurement of central venous pressure; Positive pressure supports
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: IVC diametres; Other Names: Measurement of central venous pressure; Positive pressure supports

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tepecik Training and Research Hospital
• Investigators: Principal Investigator: Tepecik Training and Research Hospital, Tepecik Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: February 25, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound,inferior vena cava, positive pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: Tepecik

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No