Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naeem Ali, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01136109
First received: May 26, 2010
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Naeem Ali, MD, Associate Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier: NCT01136109     History of Changes
Other Study ID Numbers: 2009H0143
Study First Received: May 26, 2010
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013