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

NCT01136109 | Completed

• 1 other identifier: 2009H0143
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 months

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

InpatientSample

You may qualify if:

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

You may not qualify if:

• 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).
• 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%.

Sponsors & Collaborators

• Naeem Ali, MD: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Naeem Ali, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor-Clinical

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: June 3, 2010
• Study Start: October 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

US (1)