MedPath

Preoxygenation for Tracheal Aspirations in Intensive Care

Not Applicable
Not yet recruiting
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 These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator.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
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
Read More
Exclusion Criteria
  • Not affiliated to a social security system
  • Pregnant
  • Under legal protection (curatorship, guardianship or safeguard of justice)
  • Patient under AME
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Rate of suctioning leading to deep desaturationfrom 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
NameTimeMethod
Length of hospital stayat hospital discharge, and at the latest Day 90

Length of stay in hospital

First bowel movementsFrom Day 0 to ICU-discharge, and at the latest Day 28

Time to first bowel movements

Number of ventilator free days at D28From 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 ischemiaFrom 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 infarctionFrom 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 injuryFrom 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 stayat ICU discharge, and at the latest Day 90

Length of stay in intensive care

Suctioning rate leading to severe desaturationFrom 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 ischemiaFrom 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 statusAt ICU discharge and at the latest Day 90

Vital status at discharge from ICU

Hospital discharge vital statusAt hospital discharge, and at the latest Day 90

Vital status at discharge from hospital

Cardiac arrestFrom 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 desaturationFrom Day 0 to ventilator weaning, and at the latest Day 28

For each desaturation, time in minutes between endotracheal suctioning and desaturation

Ventilator-associated pneumoniaFrom 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 deliriumFrom 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 strokeFrom 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-suctioningFrom 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

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