Preoxygenation for Tracheal Aspirations in Intensive Care
- Conditions
- ICU Patients Under Invasive Mechanical Ventilation
- Registration Number
- NCT06421012
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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 These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator.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.
- Detailed Description
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. Endotracheal suctioning are performed when the patient is "unable to clear the airways of obstructions hindering the free passage of air." Classically, endotracheal suctioning cause transient desaturation exacerbated by a decrease in cardiac output due to an increase in mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, i.e., 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 and/or disconnecting the patient from the ventilator.
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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2260
- 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
- Not affiliated to a social security system
- Pregnant
- Under legal protection (curatorship, guardianship or safeguard of justice)
- Patient under AME
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Length of hospital stay at hospital discharge, and at the latest Day 90 Length of stay in hospital
First bowel movements From Day 0 to ICU-discharge, and at the latest Day 28 Time to first bowel movements
Number of ventilator free days at D28 From Day 0 to Day 28 Number of days without ventilation. In case of death value will be set to zero
Composite criteria of ischemic phenomena in ICU, including one of the following: stroke, myocardial infarction, digestive ischemia From Day 0 to ICU-discharge, and at the latest Day 28 Composite criteria including at least one of the following: ischemic stroke, myocardial infarction, digestive ischemia
Myocardial infarction From Day 0 to ICU-discharge, and at the latest Day 28 Myocardial infarction occurring in intensive care, defined by an acute coronary syndrome with ST segment elevation and troponin elevation
Acute kidney injury From Day 0 to ICU-discharge, and at the latest Day 28 Acute kidney injury occurring in intensive care, defined by the initiation of renal replacement therapy
Length of ICU stay at ICU discharge, and at the latest Day 90 Length of stay in intensive care
Suctioning rate leading to severe 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 severe desaturation (SpO2 85% or less, and 80% or less for patients with COPD), divided by the total number of endotracheal suctioning throughout the period
Digestive ischemia From Day 0 to ICU-discharge, and at the latest Day 28 Digestive ischemia occurring in intensive care, diagnosed by CT scan or digestive endoscopy
ICU discharge vital status At ICU discharge and at the latest Day 90 Vital status at discharge from ICU
Hospital discharge vital status At hospital discharge, and at the latest Day 90 Vital status at discharge from hospital
Cardiac arrest From Day 0 to ICU-discharge, and at the latest Day 28 Cardiac arrest occuring in intensive care
Time in minutes between endotracheal suctioning and eventual desaturation From Day 0 to ventilator weaning, and at the latest Day 28 For each desaturation, time in minutes between endotracheal suctioning and desaturation
Ventilator-associated pneumonia From Day 0 to ICU-discharge, and at the latest Day 28 Ventilator-associated pneumonia, as defined by the Formalized Recommendation of Experts from the SFAR-SRLF in 2017
Intensive care delirium From Day 0 to ICU-discharge, and at the latest Day 28 Delirium occurring in ICU, defined by a positive result on the CAM-ICU clinical assessment tool specific to ICU delirium
Ischemic stroke From Day 0 to ICU-discharge, and at the latest Day 28 Ischemic stroke occurring in intensive care, defined by the combination of the onset of focal motor deficit and compatible cerebral imaging
Mean saturation over 15 minutes post-suctioning From Day 0 to ventilator weaning, and at the latest Day 28 Mean saturation over all the period of 15 minutes post suctioning
Acute respiratory distress syndrome (ARDS) From Day 0 to hospital discharge, and at the latest Day 90 ARDS according to the Berlin definition, characterized by 1) acute respiratory failure evolving for a week or less, 2) bilateral opacities on thoracic imaging, 3) no evidence of predominant hydrostatic edema, 4) hypoxemia with a PaO2/FIO2 ratio \< 300 mmHg for positive end-expiratory pressure set at 5 cmH2O or more, with 3 severity stages defined based on hypoxemia
Trial Locations
- Locations (1)
Hôpital Pitié Salpêtrière
🇫🇷Paris, France