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Management of Moderately Hypoxemic Thoracic Trauma
Sponsor: University Hospital, Brest
Summary
In France, the average incidence of thoracic trauma is 10,000 to 15,000 each year. These patients are at risk of early and late post traumatic respiratory complications as follows: pneumonia, Acute Respiratory Distress Syndrome (ARDS), hypoxemia. Main issues of thoracic trauma management were recently published by French anesthesiologist and intensivist experts. Non-invasive ventilation (NIV) was recommended in case of severe hypoxemia (PaO2/FiO2 \< 200). In comparison to conventional oxygenation or mechanical ventilation, NIV reduced length of stay, incidence of complications and mortality in case of severe hypoxemia. For mild or moderate hypoxemic patients, no devices were tested to prevent respiratory complications. At the moment, low-flow oxygenation is administered to these patients in the absence of severe hypoxemia. Recently, many studies have found promising results with high-flow oxygenation delivered by nasal cannula. This device has many physiological advantages: wash out the naso-pharyngeal dead space, increase end expiratory lung volume, deliver a moderate or low level of Positive end-expiratory pressure (PEEP), improve work of breathing and confort. Several randomized controlled trials tested this device in many clinical settings, but there are no studies on its use after thoracic trauma. A comparative trial is needed to evaluate early prophylactic administration of high-flow oxygenation after thoracic trauma.
Official title: Post Traumatic Early Use of High Flow Oxygenation Versus Standard Oxygen for Management of Moderately Hypoxemic Thoracic Trauma: TrOMaTho Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
770
Start Date
2019-11-12
Completion Date
2026-02
Last Updated
2025-05-14
Healthy Volunteers
No
Conditions
Interventions
High flow Oxygenation
Interventional group: All patients included in this group will receive a continuous heated and humidified high-flow (30 to 60 l/min) oxygenation with a nasal cannula for 48 hours. Initially, flow rate will be started at 50 l/min with a FiO2 at 50%. According to the protocol, flow rate and FiO2 will be titrated on SpO2 and respiratory tolerance. Weaning and failure of high-flow oxygenation are described in detail in the study protocol.
Standard oxygen
Control group: All patients included in this group will receive a low flow oxygenation (flow rate \< 15 l/min) with nasal cannula (flow rate ≤ 6 l/min) or non-rebreathing mask (flow rate ≥ 7 l/min).
Locations (18)
Centre Hospitalier de Cornouaille
Quimper, Brittany Region, France
Angers university hospital
Angers, France
CHU de Brest
Brest, France
Chartres Hospital
Chartres, France
HIA Percy
Clamart, France
Dreux hospital
Dreux, France
Le Mans hospital
Le Mans, France
Centre Hospitalier de Bretagne Sud
Lorient, France
La Timone Hospital (AP-HM)
Marseille, France
Marseille university horpital
Marseille, France
CHRU de Montpellier
Montpellier, France
Morlaix hospital
Morlaix, France
Nantes university hospital
Nantes, France
CHRU de la Pitié-Salpétrière
Paris, France
Kremlin Bicêtre university hospital (APHP)
Paris, France
Rennes, university Hospital
Rennes, France
Tours university hospital
Tours, France
CHBA de Vannes
Vannes, France