A Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index

A Prospective Pilot Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01136109

Acronym

IVCCI

Enrollment

Registered

2010-06-03

Start date

2009-10-31

Completion date

2013-02-28

Last updated

2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Brief summary

Previous research has shown that the Inferior Vena Cava Collapsibility Index (IVCCI) can be used to assess volume status. One limitation of the previous work is that changes in intra-thoracic pressure can influence this measurement, and the magnitude of this effect has never been described. The investigators aim is to correlate the degree of change in IVCCI with the set degree of change in intra-thoracic pressure in a heterogeneous population of critically ill patients.

Detailed description

Initially eligible patients will be those admitted to the OSU MICU and 8ICU within the prior 48 hours. These patients will be screened for predetermined exclusion criteria. Eligible patients will have their IVCCI measured and baseline peak and plateau pressures noted. For those patients meeting a second set of criteria, a common ventilator maneuver will be preformed. The positive end-expiratory pressure will be increased by 5-10 cm/H20 pressure. This procedure will be aborted if ANY safety criteria are exceeded. During the interval, the IVCCI will be re-measured, the ventilator settings will be recorded, and the ventilator will be return to the initial settings. Since changes of these same magnitude are made daily in clinical practice, the risks to the patients in this study will be minimal and no more than that experienced in the course of usual care.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

1. Age\>17 years 2. Current use of mechanical ventilation through an endotracheal tube. 3. Admitted to ICU within last 48 hours

Exclusion criteria

1. Severe COPD by history (documented FEV1\<50% predicted or CT evidence of emphysema) 2. Current suspected Asthma Exacerbation 3. Profound Hypoxia defined as a FiO2 requirement \>90% or a PEEP \>10 mmHg 4. Patient-ventilator desynchrony or active agitation 5. Unstable O2 requirement as determined by the primary clinical team. 6. Prisoners 7. Bedside clinician refusal (physician or treating nurse).

Design outcomes

Primary

Measure	Time frame	Description
Determine the effect of an increase in positive end-expiratory pressure on intrathoracic pressure variables in patients with acute respiratory failure.	24 months	1. Determine the effect on inferior vena cava collapsibility index of an increase in positive end-expiratory pressure (and resultant change in mean airway pressure) in patients with acute respiratory failure. 2. Determine the effect on central venous pressure of an increase in positive end-expiratory pressure (and resultant change in mean airway pressure) in patients with acute respiratory failure. 3. Determine the effect on mean airway pressure of an increase in positive end-expiratory pressure in patients with acute respiratory failure.

Secondary

Measure	Time frame
Determine the inter-rater reliability in obtaining inferior vena cava collapsibility index ultrasound images.	24 months
Determine the relationship between central venous pressure and inferior vena cava collapsibility index at varying levels of mean airway pressure (MAP).	24 Months

Countries

United States

Outcome results