Ireland
--:--IST
Recruiting Not applicable

Preoxygenation for Tracheal Aspirations in Intensive Care

NCT06421012 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-01-07
Last updated
2025-05-11

Condition(s) studied

ICU Patients Under Invasive Mechanical Ventilation

Investigational drug(s) / intervention(s)

Experimental : Patients without additional preoxygenationActive Comparator : Patients with additional preoxygenation

Experimental : Patients without additional preoxygenation: Throughout the entire period of their mechanical ventilation, patients will not receive additional preoxygenation before any endotracheal suctioning; their FiO2 value will be maintained constant

Active Comparator : Patients with additional preoxygenation: Throughout the entire period of their mechanical ventilation, patients will receive additional preoxygenation at 100% FiO2 for a systematic 2-minute duration prior to any endotracheal suction. Subsequently, the FiO2 will be reset to the previous default value.

Study 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 These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator.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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of suctioning leading to deep desaturation — from Day 0 to ventilator weaning, and at the latest Day 28
    It will be calculated for each patient as the number of suctioning leading to deep desaturation (SpO2 88% or less, and 85% or less for patients with chronic obstructive pulmonary disease COPD), divided by the total number of endotracheal suctioning throughout the period. Oxygen saturation values will be collected every minute during the 15 minutes post-suctioning. Endotracheal suctioning in patients already ventilated with 100% FiO2 started prior to the decision to aspirate will not be taken into account

Trial sites (1)

FacilityCityRegionStatus
Hôpital Pitié Salpêtrière Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06421012 on ClinicalTrials.gov ↗ ← All trials in France