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Management of Moderately Hypoxemic Thoracic Trauma (TrOMaTho)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997630
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment Phase
Chest Trauma High Flow Oxygenation Device: High flow Oxygenation Device: Standard oxygen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post Traumatic Early Use of High Flow Oxygenation Versus Standard Oxygen for Management of Moderately Hypoxemic Thoracic Trauma: TrOMaTho Study
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional group
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: 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.

Active Comparator: Control group
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).
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).




Primary Outcome Measures :
  1. safety event [ Time Frame: Day 28 ]

    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)


Secondary Outcome Measures :
  1. Severe hypoxemia [ Time Frame: day 7 ]
    Severe hypoxemia before day 7: SpO2 < 92% or PaO2/FiO2 < 200 without oxygenation

  2. Severe hypoxemia [ Time Frame: day 14 ]
    Severe hypoxemia before day 14: SpO2 < 92% or PaO2/FiO2 < 200 without oxygenation

  3. Respiratory tract infection [ Time Frame: day 7 ]
    Respiratory tract infection before day 7 defined according to international recommendations on health-associated pneumonia or trachea-bronchitis.

  4. Respiratory tract infection [ Time Frame: day 14 ]
    Respiratory tract infection before day 14 defined according to international recommendations on health-associated pneumonia or trachea-bronchitis.

  5. Mechanical ventilation [ Time Frame: day 7 ]
    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.

  6. Mechanical ventilation [ Time Frame: day 14 ]
    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.

  7. oxygen free days [ Time Frame: day 14 ]
    number of day without oxygen

  8. ventilator free days [ Time Frame: day 14 ]
    number of day without ventilation

  9. ICU length of stay [ Time Frame: day 90 ]
    number of day in ICU

  10. Hospital length of stay [ Time Frame: day 90 ]
    number of day of the total stay in hospital

  11. All cause of mortality [ Time Frame: day 28 or day 90 ]
    Mortality (yes/no)

  12. quality of life 3 months after High flow oxgenation with the The Short Form (36) Health Survey score [ Time Frame: day 90 ]
    SF 36 questionnary total score

  13. Severity of dyspnea using a Saint Georges respiratory questionnaire [ Time Frame: day 90 ]
    Saint Georges questionnary total score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Recommended indication for NIV: cardiogenic pulmonary oedema, decompensated COPD.
  • Indication to immediate oro-tracheal intubation. In the particular case of an IOT for surgery, also will be excluded patients requiring thoracic or abdominal surgery by laparotomy during the first 48 hours (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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997630


Contacts
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Contact: Véronique Vermeersch, Dr +33298347288 veronique.vermeersch@chu-brest.fr
Contact: Olivier Huet, Pr +33298347288 olivier.huet@chu-brest.fr

Locations
Show Show 17 study locations
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03997630    
Other Study ID Numbers: 29BRC18.0159 ( TrOMaTho)
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries