Monitoring oxygen levels during intubation in critically ill patients
Feasibility of End-tidal Oxygen Concentration Monitoring During Preoxygenation for Intubation in the Intensive Care Unit. First Part, Preliminary Study of the IMPROVE Global Project
This study is testing if monitoring oxygen levels in two places during intubation can help critically ill patients in the ICU get better preoxygenation than the usual methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Locations | 1 site (Orléans) |
| Trial ID | NCT05409573 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of monitoring end-tidal oxygen concentration (EtO2) during preoxygenation for intubation in critically ill patients in the intensive care unit (ICU). It involves a prospective non-comparative interventional approach where EtO2 will be measured both in the pharynx and on the facemask during the intubation procedure. The goal is to determine if this dual monitoring can provide a more accurate assessment of preoxygenation compared to traditional methods. The study will last no longer than one hour, including device setup.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require intubation in the ICU due to acute respiratory failure.
Not a fit: Patients requiring intubation for cardiac arrest or those who cannot undergo EtO2 monitoring will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved safety and outcomes during intubation in critically ill patients by ensuring adequate preoxygenation.
How similar studies have performed: While monitoring EtO2 is standard in operating rooms, this specific application in the ICU setting is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Requiring an intubation in ICU for acute respiratory failure defined as a respiratory rate ≥ 25/min or clinical signs of respiratory distress or hypoxemia defined as oxygen requirement ≥ 15L/min or FiO2 ≥80% to maintain SpO2 ≥92% or a PaO2/FiO2 ratio \<100 mmHg * With preoxygenation by noninvasive ventilation Exclusion Criteria: * Intubation for cardiac arrest * EtO2 monitoring not available * Pulsed oxygen saturation monitoring specific for the study not available * Preoxygenation by high-flow nasal oxygen therapy or bag-mask ventilation * Allergy to lidocaine (for local nasal anesthesia) * Previously * Patient not affiliated or excluded from social protection, or under law protection (namely minors, pregnant or breastfeeding women, persons deprived of their liberty by court or administrative decision) * Previously included in the study
Where this trial is running
Orléans
- CHR d'ORLEANS — Orléans, France (Recruiting)
Study contacts
- Principal investigator: Mai-Anh NAY, PH — CHR d'Orléans
- Study coordinator: Mai-Anh NAY, PH
- Email: mai-anh.nay@chr-orleans.fr
- Phone: +33238575253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.