Recruiting NCT06421012

Preoxygenation for Tracheal Aspirations in Intensive Care

No phase Interventional ICU Patients Under Invasive Mechanical Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Experimental : Patients without additional preoxygenation, Active Comparator : Patients with additional preoxygenation.
Who it may be relevant to: Registry conditions: ICU Patients Under Invasive Mechanical Ventilation. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator.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

Detailed description

Today, 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 rare without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. In the short term, it induces de-nitrogenation atelectasis resulting in a loss of lung volume that can worsen pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation is responsible for transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, is juxtaposed with a medium-term risk of hyperoxia and de-nitrogenation.

The investigators hypothesize that the absence of additional preoxygenation is not inferior, in terms of deep desaturations, to the strategy with additional preoxygenation, and it would avoid exposing patients to the risks of de-nitrogenation-induced atelectasis and hyperoxia.

The investigators retained a margin of non-inferiority for the relative risk of 1.1, i.e. an increase of 10% of deep desaturations.

The main analysis will be performed on the per-protocol population (more conservative in non-inferiority trials).The per-protocol population will include patients who had at least one suctioning and for whom the additional preoxygenation strategy allocated by randomisation was followed in at least 70% of all suctioning reported in the patient's care record. Patients who stopped their participation in the study before endpoint timeframe and those who had never had an suctioning will not be included in the per protocol population.

The unit of analysis will be the patient, and a rate of suctioning leading to deep desaturation will be calculated for each patient, as described in the primary endpoint. The mean rate of suctioning leading to deep desaturation will then be calculated by treatment group (with additional preoxygenation / without additional preoxygenation).

Interventions

Procedure 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
Procedure 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.

Primary outcome measures

Rate of suctioning leading to deep desaturation [Time frame: from Day 0 to ventilator weaning, and at the latest Day 28]

Secondary outcome measures (12)

Suctioning rate leading to severe desaturation [Time frame: From Day 0 to ventilator weaning, and at the latest Day 28]
Number of ventilator free days at D28 [Time frame: From Day 0 to Day 28]
Ventilator-associated pneumonia [Time frame: From Day 0 to ICU-discharge, and at the latest Day 28]
Intensive care delirium [Time frame: From Day 0 to ICU-discharge, and at the latest Day 28]
Composite criteria of ischemic phenomena in ICU, including one of the following: stroke, myocardial infarction, digestive ischemia [Time frame: From Day 0 to ICU-discharge, and at the latest Day 28]
Ischemic stroke [Time frame: From Day 0 to ICU-discharge, and at the latest Day 28]
Myocardial infarction [Time frame: From Day 0 to ICU-discharge, and at the latest Day 28]
Digestive ischemia [Time frame: From Day 0 to ICU-discharge, and at the latest Day 28]
Cardiac arrest [Time frame: From Day 0 to ICU-discharge, and at the latest Day 28]
Acute kidney injury [Time frame: From Day 0 to ICU-discharge, and at the latest Day 28]
First bowel movements [Time frame: From Day 0 to ICU-discharge, and at the latest Day 28]
ICU discharge vital status [Time frame: At ICU discharge and at the latest Day 90]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Supportive care

Study locations

France · 1 center

Hôpital Pitié Salpêtrière — Paris

Identifiers

NCT: NCT06421012 · APHP230486 · 2023-A00694-41

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗