Informations générales (source: ClinicalTrials.gov)
Post Traumatic Early Use of High Flow Oxygenation Versus Standard Oxygen for Management of Moderately Hypoxemic Thoracic Trauma: TrOMaTho Study (TrOMaTho)
Interventional
N/A
University Hospital, Brest (Voir sur ClinicalTrials)
novembre 2019
février 2026
03 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HIA PERCY | Pierre PASQUIER, MD, PhD | Contact (sur clinicalTrials) | |||
| HOPITAL COCHIN TARNIER APHP | Jacques Duranteau, MD, PhD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Angers university hospital - Angers - France | Sigismond Lasocki, MD, PhD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Bretagne Sud - 56100 - Lorient - France | Pierre Bouju, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Cornouaille - 29000 - Quimper - Bretagne - France | Mikaël Moriconi, MD | Contact (sur clinicalTrials) | |||
| Morlaix hospital - Morlaix - France | Pierre-Yves Egreteau, MD | Contact (sur clinicalTrials) | |||
| Rennes, university Hospital - 35000 - Rennes - France | Thomas LEBOUVIER, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chartres Hospital - 28000 - Chartres - France | Juliette AUDIBERT, MD | Contact (sur clinicalTrials) | |||
| CHBA de Vannes - 56017 - Vannes - France | Angélique GOEPP, MD | Contact (sur clinicalTrials) | |||
| CHRU de la Pitié-Salpétrière - 75651 - Paris - France | Mathieu RAUX, MD,PhD | Contact (sur clinicalTrials) | |||
| CHRU de Montpellier - 34295 - Montpellier - France | Jonathan Charbit, MD | Contact (sur clinicalTrials) | |||
| CHU de Brest - 29200 - Brest - France | Véronique VERMEERSCH, MD | Contact (sur clinicalTrials) | |||
| Dreux hospital - Dreux - France | Aude GARIN, MD, PhD | Contact (sur clinicalTrials) | |||
| La Timone Hospital (AP-HM) - 13005 - MArseille - France | Jeremy BOURENNE, MD | Contact (sur clinicalTrials) | |||
| Le Mans hospital - Le Mans - France | Charlène LE MOAL, MD | Contact (sur clinicalTrials) | |||
| Marseille university horpital - Marseille - France | Gary DUCLOS, MD, PhD | Contact (sur clinicalTrials) | |||
| Nantes university hospital - Nantes - France | Karim Asehnoune, MD, PhD | Contact (sur clinicalTrials) | |||
| Tours university hospital - Tours - France | Martine Ferrandiere, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Major patient (age ≥ 18 years),
- Admitted to intensive care unit for less than 48 hours for the management of chest
trauma.
- Closed chest trauma, non-penetrating, with a TTSS score> or equal to 4.
- Need for conventional oxygen therapy to maintain SpO2 greater than or equal to 95%.
- Patient affiliated or beneficiary of a social security scheme
- Patient having signed a consent
- Major patient (age ≥ 18 years),
- Admitted to intensive care unit for less than 48 hours for the management of chest
trauma.
- Closed chest trauma, non-penetrating, with a TTSS score> or equal to 4.
- Need for conventional oxygen therapy to maintain SpO2 greater than or equal to 95%.
- Patient affiliated or beneficiary of a social security scheme
- Patient having signed a consent
- Severe hypoxemia defined as a PaO2/FiO2 ratio < 200 noted before randomization
- Recommended indication for NIV: cardiogenic pulmonary oedema, decompensated COPD.
- Indication to immediate oro-tracheal intubation. (will not be excluded patients
requiring general anaesthesia for a surgical procedure for a peripheral surgical
procedure or embolization)
- Patient with acute respiratory distress, whatever the cause.
- Hemodynamic instability marked by a fall of the PAS> 30% or a PAS <110 mmHg
despite the initial resuscitation measures
- Neurological degradation with Glasgow score less than 12
- Pregnant or lactating woman
- Patient under guardianship or curatorship
- Contraindication to the use of one or both devices studied (decaying facial trauma)