In blunt chest trauma patients without immediate life-threatening conditions, delayed respiratory failure and need for mechanical ventilation may still occur in 12 to 40% of patients, depending on the severity of the trauma, the preexisting conditions and the intensity of initial management. In this context, non-invasive ventilation (NIV) is recommended in hypoxemic chest trauma patients, defined as a PaO2/FiO2 ratio \< 200 mmHg. However, there is a large heterogeneity among studies regarding the severity of injuries, the degree of hypoxemia and the timing of enrollment. The interest of a preventive strategy during the early phase of blunt chest trauma, before the occurrence of respiratory distress or severe hypoxemia, is not formally established in the literature. Moreover, high-flow nasal oxygen therapy (HFNC-O2) appears to be a reliable and better tolerated alternative to conventional oxygen therapy (COT), associated with a significant reduction in intubation rate in hypoxemic patients. Two NIV strategies are compared: 1. In the experimental strategy, NIV is performed after inclusion in patients with moderate hypoxemia, defined by a PaO2/FiO2 ratio \< 300 mmHg. The minimally required duration of NIV was 4 hours per day for at least 2 calendar days. 2. In the control group, patients receive oxygen from nasal cannula or high concentration oxygen mask according to the FiO2 needed to achieve SpO2 \> 92%. NIV is initiated only in patients having PaO2/FiO2 ratio \< 200 mmHg under COT. Investigators hypothesized that an early strategy associating HFNC-O2 and preventive NIV in hypoxemic blunt chest trauma patients may reduce the need for mechanical ventilation compared to the recommended strategy associating COT and late NIV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
144
In the experimental strategy, NIV is performed after inclusion in patients with moderate hypoxemia, defined by a PaO2/FiO2 ratio \< 300 mmHg. The minimally required duration of NIV was 4 hours per day for at least 2 calendar days. The daily duration of NIV can be increased at the discretion of the physician in patients with signs of delayed respiratory failure under HFNC-O2 and improving under NIV. Beyond the first 48 hours, NIV and HFNC-O2 can be stopped and the patient switched to COT if respiratory rate \< 25/min and SpO2 \> 92% under FiO2 \< 30% for at least 6 hours.
In the control group, patients receive oxygen from nasal cannula or high concentration oxygen mask according to the FiO2 needed to achieve SpO2 \> 92%. NIV is initiated only in patients having PaO2/FiO2 ratio \< 200 mmHg under COT. A trial of curative NIV is allowed at the discretion of the physician in patients who have signs of delayed respiratory failure and no other organ dysfunction. The non-improvement of respiratory conditions after 1 hour of NIV, the NIV-dependence (≥ 12 consecutive hours) or NIV-intolerance should be considered as criteria for endotracheal intubation.
CHU Amiens-Picardie
Amiens, France
CH d'Annecy
Annecy, France
CHU de Bordeaux
Bordeaux, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
APHP - Hôpital Beaujon
Clichy, France
AP-HM - Hôpital de la Timone
Marseille, France
CHU de Nîmes
Nîmes, France
CH de Pau
Pau, France
HCL - Hôpital Lyon Sud
Pierre-Bénite, France
CHU de Poitiers
Poitiers, France
...and 4 more locations
Necessity to perform endotracheal intubation
To ensure the consistency of indications across sites and reduce the risk of delayed intubation, the following criteria for endotracheal intubation must be used (only one criterion is needed): cardiac arrest or significant hemodynamic instability, deterioration of neurologic status, signs of persisting or worsening respiratory failure as defined by at least two of the following criteria: respiratory rate of more than 35 breaths per minute, lack of improvement in signs of high respiratory-muscle workload, development of copious tracheal secretions, signs of respiratory exhaustion (pH \<7.32 or PaCO2 \> 50 mmHg), major hypoxemia (PaO2/FiO2 ratio \<100 or SpO2 \<92% for more than 5 minutes).
Time frame: Up to 14 days after randomization
PaO2/FiO2 ratio
Time frame: every 6 hours during the first 48 hours after randomization
Respiratory rate
Time frame: every 6 hours during the first 48 hours after randomization
Dyspnea score
Dyspnea score : +2 = significant improvement; +1 = slight improvement; 0 = no change; -1 = slight deterioration ; -2 = significant deterioration
Time frame: every 6 hours during the first 48 hours after randomization
ICU and hospital length of stay
Time frame: Up to 14 days after randomization
ICU or in-hospital mortality
Time frame: Up to 14 days after randomization
Number of ventilator free-days
Days alive and without invasive or non-invasive mechanical ventilation
Time frame: Up to 14 days after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.