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

Respiratory Failure Clinical Trial

— IVCCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136109
• Other study ID #: 2009H0143
• Status: Completed
• Start date: October 2009
• Est. completion date: February 2013

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Naeem Ali, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the effect of an increase in positive end-expiratory pressure on intrathoracic pressure variables in patients with acute respiratory failure.	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.	24 months
Secondary	Determine the inter-rater reliability in obtaining inferior vena cava collapsibility index ultrasound images.		24 months
Secondary	Determine the relationship between central venous pressure and inferior vena cava collapsibility index at varying levels of mean airway pressure (MAP).		24 Months