NCT05409573 Feasibility of End-tidal Oxygen Concentration Monitoring During Preoxygenation for Intubation in the Intensive Care Unit.
| NCT ID | NCT05409573 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional d'Orléans |
| Condition | Critically Ill |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-12-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-12-23 with a primary completion date of 2027-12.
⚠ 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
Intubation is a common procedure in the intensive care unit. Hypoxemia is the most frequent complication of this procedure. Monitoring the end-tidal of oxygen is recommended in operating room (OR). End-tidal of oxygen (EtO2) \>90% is an indication of a correct preoxygenation. This monitoring is not used in routine in intensive care unit (ICU). There is no recommendation on the monitoring of end-tidal of oxygen in intensive care unit. In practice, clinicians use pulsed oxygen saturation (SpO2) to determine whether the patient is sufficiently preoxygenated. However, this parameter is not a good indicator of a correct preoxygenation. In the OR, patients are compliant during the preoxygenation period and the measure of EtO2 with the face mask monitor is considered reliable because i) mask leakage is minimal and ii) the patient can breathe slowly and regularly. Theses conditions are not available in critical ill patients requiring emergency intubation. EtO2 measured on the facemask may not reflect true EtO2. This concern about the reliability of EtO2 measurement via the facemask justifies that we conduct a study to compare EtO2 measured on a facemask (facemask EtO2) to EtO2 measured in pharynx (via e nasopharyngeal catheter). The aim of this study is to determine whether the measurement of EtO2 on facemask is reliable in patients in ICU.
Eligibility 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
Contact & Investigator
Mai-Anh NAY, PH
PRINCIPAL INVESTIGATOR
CHR d'Orléans
Frequently Asked Questions
Who can join the NCT05409573 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critically Ill. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05409573 currently recruiting?
Yes, NCT05409573 is actively recruiting participants. Contact the research team at mai-anh.nay@chr-orleans.fr for enrollment information.
Where is the NCT05409573 trial being conducted?
This trial is being conducted at Orléans, France.
Who is sponsoring the NCT05409573 clinical trial?
NCT05409573 is sponsored by Centre Hospitalier Régional d'Orléans. The principal investigator is Mai-Anh NAY, PH at CHR d'Orléans. The trial plans to enroll 30 participants.