RecruitingNot ApplicableNCT06421012

Preoxygenation for Tracheal Aspirations in Intensive Care

Preoxygenation for Tracheal Aspirations in Intensive Care, a Randomized Controlled Trial


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

2,260 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

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 These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator.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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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

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Interventions

PROCEDUREExperimental : 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

PROCEDUREActive 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.


Locations(1)

Hôpital Pitié Salpêtrière

Paris, France

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NCT06421012