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Management of Moderately Hypoxemic Thoracic Trauma (TrOMaTho)

Primary Purpose

Chest Trauma, High Flow Oxygenation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High flow Oxygenation
Standard oxygen
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chest Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre Hospitalier de CornouailleRecruiting
  • Angers university hospitalRecruiting
  • Brest university hospitalRecruiting
  • Chartres HospitalRecruiting
  • HIA PercyRecruiting
  • Dreux hospitalRecruiting
  • Le Mans hospitalRecruiting
  • Centre Hospitalier de Bretagne SudRecruiting
  • La Timone Hospital (AP-HM)
  • Marseille university horpitalRecruiting
  • CHRU de MontpellierRecruiting
  • Morlaix hospitalRecruiting
  • Nantes university hospitalRecruiting
  • CHRU de la Pitié-SalpétrièreRecruiting
  • Kremlin Bicêtre university hospital (APHP)Recruiting
  • Rennes, university HospitalRecruiting
  • Tours university hospitalRecruiting
  • CHBA de VannesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

Control group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2019
Last Updated
February 7, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03997630
Brief Title
Management of Moderately Hypoxemic Thoracic Trauma
Acronym
TrOMaTho
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Trauma, High Flow Oxygenation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
770 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique Vermeersch, Dr
Phone
+33298347288
Email
veronique.vermeersch@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Huet, Pr
Phone
+33298347288
Email
olivier.huet@chu-brest.fr
Facility Information:
Facility Name
Centre Hospitalier de Cornouaille
City
Quimper
State/Province
Bretagne
ZIP/Postal Code
29000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikaël Moriconi, MD
Phone
+33298526515
Email
m.moriconi@chcormouaille.fr
First Name & Middle Initial & Last Name & Degree
Mikaël Moriconi
Facility Name
Angers university hospital
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigismond Lasocki, MD, PhD
Phone
+33241353635
Email
silasocki@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Sigismond Lasocki, MD, PhD
Facility Name
Brest university hospital
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Huet, MD,PhD
Phone
+33298347288
Email
olivier.huet@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Olivier Huet, MD,PhD
First Name & Middle Initial & Last Name & Degree
Véronique Vermeersch, MD
Facility Name
Chartres Hospital
City
Chartres
ZIP/Postal Code
28000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette AUDIBERT, MD
Phone
+33237303239
Email
jaudibert@ch-chartres.fr
First Name & Middle Initial & Last Name & Degree
Pierre Kalfon, MD
Facility Name
HIA Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre PASQUIER, MD, PhD
Phone
+33141466726
Email
pasquier9606@me.com
First Name & Middle Initial & Last Name & Degree
Pierre PASQUIER, MD, PhD
Facility Name
Dreux hospital
City
Dreux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude GARIN, MD, PhD
Phone
+33237517633
Email
agarin@ch-dreux.fr
First Name & Middle Initial & Last Name & Degree
GARIN Aude, MD, PhD
Facility Name
Le Mans hospital
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlène LE MOAL, MD
Email
clemoal@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Mickael Landais, MD
Phone
+33243432458
Email
mlandais@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Charlène LE MOAL, MD
First Name & Middle Initial & Last Name & Degree
Mickael Landais, MD
Facility Name
Centre Hospitalier de Bretagne Sud
City
Lorient
ZIP/Postal Code
56100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Bouju, MD
Email
p.bouju@ch-bretagne-sud.fr
First Name & Middle Initial & Last Name & Degree
Pierre Bouju, MD
Facility Name
La Timone Hospital (AP-HM)
City
MArseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy BOURENNE, MD
Phone
+334 13 42 95 31
Email
jeremy.bourenne@aphm.fr
First Name & Middle Initial & Last Name & Degree
Jeremy BOURENNE, MD
Facility Name
Marseille university horpital
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary DUCLOS, MD, PhD
Email
gary.duclos@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Marc LEONE
Email
marc.leone@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Gary DUCLOS, MD
First Name & Middle Initial & Last Name & Degree
Marc LEONE, MD, PhD
Facility Name
CHRU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Charbit, MD
Phone
+33467338256
Email
j-charbit@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Jonathan Charbit, MD
Facility Name
Morlaix hospital
City
Morlaix
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves Egreteau, MD
Phone
+33298626095
Email
PEgreteau@ch-morlaix.fr
First Name & Middle Initial & Last Name & Degree
Pierre-Yves Egreteau, MD
Facility Name
Nantes university hospital
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Asehnoune, MD, PhD
Phone
+33240083005
Email
karim.asehnoune@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Karim Asehnoune, MD, PhD
Facility Name
CHRU de la Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu RAUX, MD,PhD
Email
mathieu.raux@aphp.fr
First Name & Middle Initial & Last Name & Degree
Arthur JAMES, MD,PhD
Email
arthur.james@aphp.fr
First Name & Middle Initial & Last Name & Degree
Mathieu Raux, MD,PhD
First Name & Middle Initial & Last Name & Degree
Arthur JAMES, MD
Facility Name
Kremlin Bicêtre university hospital (APHP)
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Duranteau, MD, PhD
Phone
+33145213936
Email
jacques.duranteau@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jacques Duranteau, MD, PhD
Facility Name
Rennes, university Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas LEBOUVIER, MD
Email
thomas.lebouvier@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Philippe SEGUIN, MD,PhD
Email
philippe.seguin@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Thomas LEBOUVIER, MD
First Name & Middle Initial & Last Name & Degree
Philippe SEGUIN, MD,PhD
Facility Name
Tours university hospital
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Ferrandiere, MD, PhD
Phone
+33247475997
Email
m.ferrandiere@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Martine Ferrandiere, MD, PhD
Facility Name
CHBA de Vannes
City
Vannes
ZIP/Postal Code
56017
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angélique GOEPP, MD
Phone
+33297014306
Email
angelique.goepp@ch-bretagne-atlantique.fr
First Name & Middle Initial & Last Name & Degree
Angélique GOEPP, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Management of Moderately Hypoxemic Thoracic Trauma

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