- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438938
Measurement of Airway Opening Index During Out-of-hospital Cardiac Arrest: The Lazarus AOI Trial. (Lazarus-AOI)
Out-of-hospital cardiac arrest (OHCA) is a leading cause of death worldwide. Despite constantly improving resuscitation techniques, the chances of survival remain limited. During cardiopulmonary resuscitation (CPR), a closure of the airway may occur, impeding ventilation. This phenomenon also complicates the interpretation of the end-tidal CO2 (ETCO2) in the capnogram. The extent to which airway closure occurs is quantified by the Airway Opening Index (AOI). This can be calculated from the capnogram and is seen as a measure of the quality of CPR applied as well as a possible indicator to predict the outcome of CPR.
In this study, we analyse capnogram data from approximately 150 cases, collected during interventions for OHCA and logged in the Lazarus database (UZ Gent and AZORG) to answer three research questions below:
- What is the prevalence of AOI during CPR?
- Is there a correlation between AOI and return of spontaneous circulation (ROSC)?
- Does the application of positive end-expiratory pressure (PEEP) affect the AOI and ROSC?
A mathematical model for calculating AOI, based on a method from previous work by Bandhari et al. [1] will be developed. Using this model, the AOI will be calculated from the individual capnograms for all cases in the Lazarus database.
In addition, a multivariable regression model will be used to analyse whether AOI can be used to predict ROSC. Corrections will be made for relevant confounders such as age, gender, witnessed arrest and rhythm pattern.
Finally, it is investigated whether PEEP has a positive influence on AOI. This study aims to contribute to better insights into airway dynamics during CPR and the optimization of ventilation in OHCA.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Said Hachimi Idrissi, MD, PhD
- Phone Number: 0032 9 332 50 24
- Email: SAID.HACHIMIIDRISSI@ugent.be
Study Contact Backup
- Name: Thomas Tackaert, MD
- Email: thomas.tackaert@ugent.be
Study Locations
-
-
East-Flanders
-
Ghent, East-Flanders, Belgium, B9000
- Recruiting
- Ghent University Hospital
-
Contact:
- Said Hachimi Idrissi, MD, PhD
- Phone Number: 0032 9 332 50 24
- Email: SAID.HACHIMIIDRISSI@ugent.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (over 18 years old) patients with out-of-hospital cardiac arrest.
- Patients undergoing cardiopulmonary resuscitation (CPR).
- Patients who were intubated and had available capnogram recordings immediately after intubation.
Exclusion Criteria:
- Patients that were not intubated
- Patients that did not receive CPR following intubation
- Cases with a technical challenge with the ETCO₂ measurement (i.e., issues with waveform data of the capnogram.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
ROSC
Patients with return-of-spontaneous circulation during initial resuscitation.
|
|
non-ROSC
Patients without return-of-spontaneous circulation during initial resuscitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROSC
Time Frame: Initial resuscitation (first day)
|
Return-of-spontaneous circulation during initial resuscitation.
|
Initial resuscitation (first day)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2025-0418
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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