Respiratory FailureIVCCINCT01136109
A Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index
An observational study of Respiratory Failure, run by Naeem Ali, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Respiratory Failure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: InpatientSample
Who may be able to join
- Age>17 years
- Current use of mechanical ventilation through an endotracheal tube.
- Admitted to ICU within last 48 hours
Who cannot join
- 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
Show all 10Show fewer
- 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%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Pilot 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.
Read the 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.
- Conditions
- Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
Determine the inter-rater reliability in obtaining inferior vena cava collapsibility index ultrasound images.
Measured: 24 months
Determine the relationship between central venous pressure and inferior vena cava collapsibility index at varying levels of mean airway pressure (MAP).
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naeem Ali, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naeem Ali, MD, Ohio State University
- Investigators
- Naeem Ali, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136109
- Sponsor's protocol ID
- 2009H0143
- Acronym
- IVCCI
- Status last verified
- Mar 2024
- First submitted
- 26 May 2010
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index
- ClinicalTrials.gov ID
- NCT01136109
- Acronym / sponsor ID
- IVCCI / 2009H0143
- Conditions
- Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Naeem Ali, MDUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- InpatientSample
Key inclusion criteria (3 listed)
- Age>17 years
- Current use of mechanical ventilation through an endotracheal tube.
- Admitted to ICU within last 48 hours
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naeem Ali, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Naeem Ali, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.