Management of Moderately Hypoxemic Thoracic Trauma (TrOMaTho)

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.

Study Overview

• Status: Recruiting
• Conditions: Chest Trauma; High Flow Oxygenation
• Intervention / Treatment: Device: High flow Oxygenation; Device: Standard oxygen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 770
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Véronique Vermeersch, Dr; Phone Number: +33298347288; Email: veronique.vermeersch@chu-brest.fr
• Study Contact Backup: Name: Olivier Huet, Pr; Phone Number: +33298347288; Email: olivier.huet@chu-brest.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • Angers University Hospital
    • Principal Investigator: Sigismond Lasocki, MD, PhD
    • Contact: Sigismond Lasocki, MD, PhD; Phone Number: +33241353635; Email: silasocki@chu-angers.fr
  • Brest, France
    • Recruiting
    • Brest University Hospital
    • Contact: Olivier HUET, MD,PhD; Phone Number: +33298347288; Email: olivier.huet@chu-brest.fr
    • Principal Investigator: Olivier Huet, MD,PhD
    • Sub-Investigator: Véronique Vermeersch, MD
  • Chartres, France, 28000
    • Recruiting
    • Chartres Hospital
    • Principal Investigator: Pierre Kalfon, MD
    • Contact: Juliette AUDIBERT, MD; Phone Number: +33237303239; Email: jaudibert@ch-chartres.fr
  • Clamart, France, 92141
    • Recruiting
    • HIA Percy
    • Contact: Pierre PASQUIER, MD, PhD; Phone Number: +33141466726; Email: pasquier9606@me.com
    • Principal Investigator: Pierre PASQUIER, MD, PhD
  • Dreux, France
    • Recruiting
    • Dreux hospital
    • Contact: Aude GARIN, MD, PhD; Phone Number: +33237517633; Email: agarin@ch-dreux.fr
    • Principal Investigator: GARIN Aude, MD, PhD
  • Le Mans, France
    • Recruiting
    • Le Mans hospital
    • Contact: Mickael Landais, MD; Phone Number: +33243432458; Email: mlandais@ch-lemans.fr
    • Contact: Charlène LE MOAL, MD; Email: clemoal@ch-lemans.fr
    • Principal Investigator: Charlène LE MOAL, MD
    • Sub-Investigator: Mickael Landais, MD
  • Lorient, France, 56100
    • Recruiting
    • Centre Hospitalier de Bretagne Sud
    • Contact: Pierre Bouju, MD; Email: p.bouju@ch-bretagne-sud.fr
    • Principal Investigator: Pierre Bouju, MD
  • MArseille, France, 13005
    • Not yet recruiting
    • La Timone Hospital (AP-HM)
    • Contact: Jeremy BOURENNE, MD; Phone Number: +334 13 42 95 31; Email: jeremy.bourenne@aphm.fr
    • Principal Investigator: Jeremy BOURENNE, MD
  • Marseille, France
    • Recruiting
    • Marseille university horpital
    • Contact: Gary DUCLOS, MD, PhD; Email: gary.duclos@ap-hm.fr
    • Principal Investigator: Gary DUCLOS, MD
    • Sub-Investigator: Marc LEONE, MD, PhD
  • Montpellier, France, 34295
    • Recruiting
    • CHRU de Montpellier
    • Contact: Jonathan Charbit, MD; Phone Number: +33467338256; Email: j-charbit@chu-montpellier.fr
    • Principal Investigator: Jonathan CHARBIT, MD
  • Morlaix, France
    • Recruiting
    • Morlaix hospital
    • Contact: Pierre-Yves Egreteau, MD; Phone Number: +33298626095; Email: PEgreteau@ch-morlaix.fr
    • Principal Investigator: Pierre-Yves Egreteau, MD
  • Nantes, France
    • Recruiting
    • Nantes university hospital
    • Contact: Karim Asehnoune, MD, PhD; Phone Number: +33240083005; Email: karim.asehnoune@chu-nantes.fr
    • Principal Investigator: Karim Asehnoune, MD, PhD
  • Paris, France
    • Recruiting
    • Kremlin Bicêtre university hospital (APHP)
    • Contact: Jacques Duranteau, MD, PhD; Phone Number: +33145213936; Email: jacques.duranteau@aphp.fr
    • Principal Investigator: Jacques Duranteau, MD, PhD
  • Paris, France, 75651
    • Recruiting
    • CHRU de la Pitié-Salpétrière
    • Contact: Mathieu RAUX, MD,PhD; Email: mathieu.raux@aphp.fr
    • Contact: Arthur JAMES, MD,PhD; Email: arthur.james@aphp.fr
    • Principal Investigator: Mathieu Raux, MD,PhD
    • Sub-Investigator: Arthur JAMES, MD
  • Rennes, France, 35000
    • Recruiting
    • Rennes, University hospital
    • Contact: Thomas LEBOUVIER, MD; Email: thomas.lebouvier@chu-rennes.fr
    • Contact: Philippe SEGUIN, MD,PhD; Email: philippe.seguin@chu-rennes.fr
    • Principal Investigator: Thomas LEBOUVIER, MD
    • Sub-Investigator: Philippe SEGUIN, MD,PhD
  • Tours, France
    • Recruiting
    • Tours university Hospital
    • Contact: Martine Ferrandiere, MD, PhD; Phone Number: +33247475997; Email: m.ferrandiere@chu-tours.fr
    • Principal Investigator: Martine Ferrandiere, MD, PhD
  • Vannes, France, 56017
    • Recruiting
    • CHBA de Vannes
    • Contact: Angélique GOEPP, MD; Phone Number: +33297014306; Email: angelique.goepp@ch-bretagne-atlantique.fr
    • Principal Investigator: Angélique GOEPP, MD
  • Bretagne
    • Quimper, Bretagne, France, 29000
      • Recruiting
      • Centre Hospitalier de Cornouaille
      • Contact: Mikaël Moriconi, MD; Phone Number: +33298526515; Email: m.moriconi@chcormouaille.fr
      • Principal Investigator: Mikaël Moriconi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe hypoxemia	Severe hypoxemia before day 7: SpO2 < 92% or PaO2/FiO2 < 200 without oxygenation	day 7
Severe hypoxemia	Severe hypoxemia before day 14: SpO2 < 92% or PaO2/FiO2 < 200 without oxygenation	day 14
Respiratory tract infection	Respiratory tract infection before day 7 defined according to international recommendations on health-associated pneumonia or trachea-bronchitis.	day 7
Respiratory tract infection	Respiratory tract infection before day 14 defined according to international recommendations on health-associated pneumonia or trachea-bronchitis.	day 14
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.	day 7
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.	day 14
oxygen free days	number of day without oxygen	day 14
ventilator free days	number of day without ventilation	day 14
ICU length of stay	number of day in ICU	day 90
Hospital length of stay	number of day of the total stay in hospital	day 90
All cause of mortality	Mortality (yes/no)	day 28 or day 90
quality of life 3 months after High flow oxgenation with the The Short Form (36) Health Survey score	SF 36 questionnary total score	day 90
Severity of dyspnea using a Saint Georges respiratory questionnaire	Saint Georges questionnary total score	day 90

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2019
• Primary Completion (ANTICIPATED): February 1, 2026
• Study Completion (ANTICIPATED): February 1, 2026

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (ACTUAL): June 25, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 29BRC18.0159 ( TrOMaTho)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No