NCT03997630

Management of Moderately Hypoxemic Thoracic Trauma

Post Traumatic Early Use of High Flow Oxygenation Versus Standard Oxygen for Management of Moderately Hypoxemic Thoracic Trauma: TrOMaTho Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 770 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TrOMaTho study is an investigator-initiated, randomized, unblinded, controlled trial. The aim of this study is to compare a prophylactic use of high-flow nasal cannula oxygenation (experimental group) to low-flow oxygenation (control group) after thoracic trauma. 770 patients will be included. Randomization will be conducted with random block and patients will be randomized in 1:1 ratio in one of the two groups. Randomization process will be stratified on: age (more or less 65 years old), use of peridural analgesia and existence of extra thoracic trauma. Only the oxygenation technique is studied, all other aspects of management will be handle by the attending physician. All patients will be followed from enrollment to hospital discharge. To ensure the same data collection in all centers, six visits are planned: day (D) 1 (inclusion), D7, D14, D28. Classical blinded methods cannot be used for the evaluation of these kinds of devices. To ensure the same evaluation for all patients and in all centers, all relevant outcomes will be evaluated by an independent clinical event committee. Statistical analysis will be performed by an independent statistician. Primary endpoint will be analyzed according to intention to treat. Secondary outcomes will be analyzed as exploratory analysis.

Conditions

• Chest Trauma
• High Flow Oxygenation

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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).

Timeline

• Start date: 2019-11-12
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2019-06-25
• Last updated: 2025-05-14

Locations

18 sites across 1 country: France