NCT06421012 Preoxygenation for Tracheal Aspirations in Intensive Care
| NCT ID | NCT06421012 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | ICU Patients Under Invasive Mechanical Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,260 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2027-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
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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 2,260 participants in total. It began in 2025-01-07 with a primary completion date of 2027-10-10.
⚠ 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
Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. In intubated and ventilated patients, endotracheal suctioning occur when the patient is "unable to clear the airways of obstructions hindering the free passage of air." These suctioning can lead to transient desaturation exacerbated by a decrease in cardiac output due to increased mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, by increasing the fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the procedure. These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator. Currently, suctioning are performed on-demand, based on the patient's congestion status, either through the endotracheal tube cap or a "closed system." Desaturations have become infrequent without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. By inducing de-nitrogenation atelectasis with a loss of lung volume, it can exacerbate pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation leads to transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, must be balanced against a medium-term risk of hyperoxia and de-nitrogenation.
Eligibility Criteria
Inclusion Criteria: * 18 years of age or older * Hospitalized in ICU, under invasive mechanical ventilation for less than 24 hours * Information and signature of consent by patient or relative/trusted person, or emergency inclusion procedure Exclusion Criteria: * Patient on ECMO * Not affiliated to a social security system * Pregnant * Under legal protection (curatorship, guardianship or safeguard of justice) * Patient under AME * Patient included in another interventional study that may have an impact on the evaluation criteria of the present study
Contact & Investigator
Claire FAZILLEAU
PRINCIPAL INVESTIGATOR
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06421012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ICU Patients Under Invasive Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06421012 currently recruiting?
Yes, NCT06421012 is actively recruiting participants. Contact the research team at claire.fazilleau@aphp.fr for enrollment information.
Where is the NCT06421012 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06421012 clinical trial?
NCT06421012 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Claire FAZILLEAU at Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris. The trial plans to enroll 2,260 participants.