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Completed

NCT Number: NCT01136109

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Exclusion criteria

for ventilator changes:

  • Cardiovascular instability (any increase in rate of vasopressors or i.v. fluid bolus for hypotension within the last four hours)
  • Current PEEP requirements of >15cmH2O
  • Current SpO2 of <88%.

Treatment and study plan

Primary outcomes

  1. Determine the effect of an increase in positive end-expiratory pressure on intrathoracic pressure variables in patients with acute respiratory failure.

    Time frame: 24 months

    • 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.
    • 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.
    • Determine the effect on mean airway pressure of an increase in positive end-expiratory pressure in patients with acute respiratory failure.

Secondary outcomes

  1. Determine the inter-rater reliability in obtaining inferior vena cava collapsibility index ultrasound images.

    Time frame: 24 months

  2. Determine the relationship between central venous pressure and inferior vena cava collapsibility index at varying levels of mean airway pressure (MAP).

    Time frame: 24 Months

Sponsors and collaborators

Lead sponsor

Naeem Ali, MD

Other

Registry information

Official study title

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

Acronym: IVCCI

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 3, 2010
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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