NCT07438938 Measurement of Airway Opening Index During Out-of-hospital Cardiac Arrest: The Lazarus AOI Trial.
| NCT ID | NCT07438938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Cardiac Arrest (CA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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: 1. What is the prevalence of AOI during CPR? 2. Is there a correlation between AOI and return of spontaneous circulation (ROSC)? 3. 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07438938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrest (CA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07438938 currently recruiting?
Yes, NCT07438938 is actively recruiting participants. Contact the research team at SAID.HACHIMIIDRISSI@ugent.be for enrollment information.
Where is the NCT07438938 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT07438938 clinical trial?
NCT07438938 is sponsored by University Hospital, Ghent. The trial plans to enroll 150 participants.