Clinical trial NCT03997630: Management of Moderately Hypoxemic Thoracic Trauma
Official title: Post Traumatic Early Use of High Flow Oxygenation Versus Standard Oxygen for Management of Moderately Hypoxemic Thoracic Trauma: TrOMaTho Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chest Trauma
High Flow Oxygenation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: safety event
timeFrame: Day 28
Secondary outcomes:
measure: Severe hypoxemia
timeFrame: day 7
measure: Severe hypoxemia
timeFrame: day 14
measure: Respiratory tract infection
timeFrame: day 7
measure: Respiratory tract infection
timeFrame: day 14
measure: Mechanical ventilation
timeFrame: day 7
measure: Mechanical ventilation
timeFrame: day 14
measure: oxygen free days
timeFrame: day 14
measure: ventilator free days
timeFrame: day 14
measure: ICU length of stay
timeFrame: day 90
measure: Hospital length of stay
timeFrame: day 90
measure: All cause of mortality
timeFrame: day 28 or day 90
measure: quality of life 3 months after High flow oxgenation with the The Short Form (36) Health Survey score
timeFrame: day 90
measure: Severity of dyspnea using a Saint Georges respiratory questionnaire
timeFrame: day 90
Other outcomes:
Locations:
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
state: Bretagne
city: Angers
country: France
facility: Angers university hospital
city: Brest
country: France
facility: CHU de Brest
city: Chartres
country: France
facility: Chartres Hospital
city: Clamart
country: France
facility: HIA Percy
city: Dreux
country: France
facility: Dreux hospital
city: Le Mans
country: France
facility: Le Mans hospital
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud
city: MArseille
country: France
facility: La Timone Hospital (AP-HM)
city: Marseille
country: France
facility: Marseille university horpital
city: Montpellier
country: France
facility: CHRU de Montpellier
city: Morlaix
country: France
facility: Morlaix hospital
city: Nantes
country: France
facility: Nantes university hospital
city: Paris
country: France
facility: CHRU de la Pitié-Salpétrière
city: Paris
country: France
facility: Kremlin Bicêtre university hospital (APHP)
city: Rennes
country: France
facility: Rennes, university Hospital
city: Tours
country: France
facility: Tours university hospital
city: Vannes
country: France
facility: CHBA de Vannes
Study officials:
References: