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Chest TraumaTrOMaThoNCT03997630

Management of Moderately Hypoxemic Thoracic Trauma

A study testing High flow Oxygenation and Standard oxygen in people with Chest Trauma and High Flow Oxygenation, run by University Hospital, Brest at 18 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chest Trauma, High Flow Oxygenation
What is being tested?
High flow Oxygenation and Standard oxygen
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
770 participants
Where
18 sitesFrance
Study dates
12 Nov 2019to Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Pregnant or lactating woman
  • Patient under guardianship or curatorship
  • Contraindication to the use of one or both devices studied (decaying facial trauma)

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Angers university hospital

    Angers

  • CHU de Brest

    Brest, 29200

  • Chartres Hospital

    Chartres, 28000

  • HIA Percy

    Clamart, 92141

  • Dreux hospital

    Dreux

  • Le Mans hospital

    Le Mans

  • Centre Hospitalier de Bretagne Sud

    Lorient, 56100

  • La Timone Hospital (AP-HM)

    Marseille, 13005

  • Marseille university horpital

    Marseille

  • CHRU de Montpellier

    Montpellier, 34295

  • Morlaix hospital

    Morlaix

  • Nantes university hospital

    Nantes

  • CHRU de la Pitié-Salpétrière

    Paris, 75651

  • Kremlin Bicêtre university hospital (APHP)

    Paris

  • Centre Hospitalier de Cornouaille

    Quimper, Brittany Region, 29000

  • Rennes, university Hospital

    Rennes, 35000

  • Tours university hospital

    Tours

  • CHBA de Vannes

    Vannes, 56017

Other trials in France

About this study

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

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.

Read the 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.

Being tested
High flow Oxygenation, Standard oxygen
Medical subject headings
Thoracic Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High flow OxygenationDevice

    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 oxygenDevice

    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).

Study groups in NCT03997630
Study groupRoleWhat they receive
Interventional groupExperimentalInterventional 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.
Receives: Device: High flow Oxygenation
Control groupActive comparatorControl 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).
Receives: Device: Standard oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety event

    The primary endpoint is a composite endpoint defined by:

    • The use of non-invasive ventilation whatever the cause before the 14th day following the trauma (yes/no) OR
    • The use of orotracheal intubation whatever the cause before the 14th day following on the thoracic traumatism.(yes/no) OR
    • The death any cause confused with D28. (yes/no)

    Measured: Day 28

Secondary outcomes (13)

  1. Severe hypoxemia

    Severe hypoxemia before day 7: SpO2 < 92% or PaO2/FiO2 < 200 without oxygenation

    Measured: day 7

  2. Severe hypoxemia

    Severe hypoxemia before day 14: SpO2 < 92% or PaO2/FiO2 < 200 without oxygenation

    Measured: day 14

  3. Respiratory tract infection

    Respiratory tract infection before day 7 defined according to international recommendations on health-associated pneumonia or trachea-bronchitis.

    Measured: day 7

  4. Respiratory tract infection

    Respiratory tract infection before day 14 defined according to international recommendations on health-associated pneumonia or trachea-bronchitis.

    Measured: day 14

  5. Mechanical ventilation

    Need for mechanical ventilation before day 7. Criteria used to define the need of mechanical ventilation is an acute respiratory distress defined as: the inability to clear tracheal secretion, a deterioration of neurological status (decrease in GCS of 2 points), a respiratory acidosis (pH < 7,25 and PaCO2 > 45 mmHg), signs of persisting or worsening respiratory failure (respiratory rate > 35/min, high respiratory-muscle workload) with a poor response to another oxygenation device.

    Measured: day 7

  6. Mechanical ventilation

    Need for mechanical ventilation before day 14. Criteria used to define the need of mechanical ventilation is an acute respiratory distress defined as: the inability to clear tracheal secretion, a deterioration of neurological status (decrease in GCS of 2 points), a respiratory acidosis (pH < 7,25 and PaCO2 > 45 mmHg), signs of persisting or worsening respiratory failure (respiratory rate > 35/min, high respiratory-muscle workload) with a poor response to another oxygenation device.

    Measured: day 14

  7. oxygen free days

    number of day without oxygen

    Measured: day 14

  8. ventilator free days

    number of day without ventilation

    Measured: day 14

  9. ICU length of stay

    number of day in ICU

    Measured: day 90

  10. Hospital length of stay

    number of day of the total stay in hospital

    Measured: day 90

  11. All cause of mortality

    Mortality (yes/no)

    Measured: day 28 or day 90

  12. quality of life 3 months after High flow oxgenation with the The Short Form (36) Health Survey score

    SF 36 questionnary total score

    Measured: day 90

  13. Severity of dyspnea using a Saint Georges respiratory questionnaire

    Saint Georges questionnary total score

    Measured: day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2019
  2. Study start12 Nov 2019
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
770 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03997630
Sponsor's protocol ID
29BRC18.0159
Acronym
TrOMaTho
Status last verified
May 2025
First submitted
26 Mar 2019
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A study testing High flow Oxygenation and Standard oxygen in people with Chest Trauma and High Flow Oxygenation, run by University Hospital, Brest at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety event (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03997630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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