Management of Moderately Hypoxemic Thoracic Trauma

Chest Trauma Clinical Trial

— TrOMaTho  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03997630
• Other study ID #: 29BRC18.0159 ( TrOMaTho)
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: February 2026

Study information

• Verified date: February 2023
• Source: University Hospital, Brest
• Contact: Véronique Vermeersch, Dr
• Phone: +33298347288
• Email: veronique.vermeersch[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 770
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chest Trauma
• High Flow Oxygenation
• Wounds and Injuries

Intervention

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.
• 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).

Locations

Country	Name	City	State
France	Angers university hospital	Angers
France	Brest university hospital	Brest
France	Chartres Hospital	Chartres
France	HIA Percy	Clamart
France	Dreux hospital	Dreux
France	Le Mans hospital	Le Mans
France	Centre Hospitalier de Bretagne Sud	Lorient
France	La Timone Hospital (AP-HM)	MArseille
France	Marseille university horpital	Marseille
France	CHRU de Montpellier	Montpellier
France	Morlaix hospital	Morlaix
France	Nantes university hospital	Nantes
France	CHRU de la Pitié-Salpétrière	Paris
France	Kremlin Bicêtre university hospital (APHP)	Paris
France	Centre Hospitalier de Cornouaille	Quimper	Bretagne
France	Rennes, university Hospital	Rennes
France	Tours university hospital	Tours
France	CHBA de Vannes	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severe hypoxemia	Severe hypoxemia before day 7: SpO2 < 92% or PaO2/FiO2 < 200 without oxygenation	day 7
Secondary	Severe hypoxemia	Severe hypoxemia before day 14: SpO2 < 92% or PaO2/FiO2 < 200 without oxygenation	day 14
Secondary	Respiratory tract infection	Respiratory tract infection before day 7 defined according to international recommendations on health-associated pneumonia or trachea-bronchitis.	day 7
Secondary	Respiratory tract infection	Respiratory tract infection before day 14 defined according to international recommendations on health-associated pneumonia or trachea-bronchitis.	day 14
Secondary	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
Secondary	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
Secondary	oxygen free days	number of day without oxygen	day 14
Secondary	ventilator free days	number of day without ventilation	day 14
Secondary	ICU length of stay	number of day in ICU	day 90
Secondary	Hospital length of stay	number of day of the total stay in hospital	day 90
Secondary	All cause of mortality	Mortality (yes/no)	day 28 or day 90
Secondary	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
Secondary	Severity of dyspnea using a Saint Georges respiratory questionnaire	Saint Georges questionnary total score	day 90