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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136109
First Posted: June 3, 2010
Last Update Posted: January 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Naeem Ali, MD, The Ohio State University
  Purpose
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.

Condition
Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Pilot Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index

Resource links provided by NLM:


Further study details as provided by Naeem Ali, MD, The Ohio State University:

Primary Outcome Measures:
  • 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 ]
    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 Outcome Measures:
  • Determine the inter-rater reliability in obtaining inferior vena cava collapsibility index ultrasound images. [ Time Frame: 24 months ]
  • 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 ]

Enrollment: 32
Study Start Date: October 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bedside ultrasound only
Bedside ultrasound to determine the dimensions of the inferior vena cava
Ultrasound with ventilator changes
Bedside ultrasound to determine the dimensions of the inferior vena cava pre and post ventilator changes.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
InpatientSample
Criteria

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).

Exclusion Criteria for ventilator changes:

  1. Cardiovascular instability (any increase in rate of vasopressors or i.v. fluid bolus for hypotension within the last four hours)
  2. Current PEEP requirements of >15cmH2O
  3. Current SpO2 of <88%.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136109


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Naeem Ali, MD
Investigators
Principal Investigator: Naeem Ali, M.D. Ohio State University
  More Information

Responsible Party: Naeem Ali, MD, Associate Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier: NCT01136109     History of Changes
Other Study ID Numbers: 2009H0143
First Submitted: May 26, 2010
First Posted: June 3, 2010
Last Update Posted: January 18, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases