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ACTIVE NOT RECRUITING
NCT03997630
NA

Management of Moderately Hypoxemic Thoracic Trauma

Sponsor: University Hospital, Brest

View on ClinicalTrials.gov

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

Interventions

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).

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