Management of Moderately Hypoxemic Thoracic Trauma

NCT03997630 | Active Not Recruiting

• 1 other identifier: 29BRC18.0159
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 18

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.

Conditions

Chest Trauma; High Flow Oxygenation

Outcome Measures

Primary Outcomes (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)

  Day 28

Secondary Outcomes (13)

• Severe hypoxemia

  day 7

• Severe hypoxemia

  day 14

• Respiratory tract infection

  day 7

• Respiratory tract infection

  day 14

• Mechanical ventilation

  day 7

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

High flow Oxygenation DEVICE

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.

Interventional group

Standard oxygen DEVICE

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).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (18)

Centre Hospitalier de Cornouaille

Quimper, Brittany Region, 29000, France

Location

Angers university hospital

Angers, France

Location

CHU de Brest

Brest, 29200, France

Location

Chartres Hospital

Chartres, 28000, France

Location

HIA Percy

Clamart, 92141, France

Location

Dreux hospital

Dreux, France

Location

Le Mans hospital

Le Mans, France

Location

Centre Hospitalier de Bretagne Sud

Lorient, 56100, France

Location

La Timone Hospital (AP-HM)

Marseille, 13005, France

Location

Marseille university horpital

Marseille, France

Location

CHRU de Montpellier

Montpellier, 34295, France

Location

Morlaix hospital

Morlaix, France

Location

Nantes university hospital

Nantes, France

Location

CHRU de la Pitié-Salpétrière

Paris, 75651, France

Location

Kremlin Bicêtre university hospital (APHP)

Paris, France

Location

Rennes, university Hospital

Rennes, 35000, France

Location

Tours university hospital

Tours, France

Location

CHBA de Vannes

Vannes, 56017, France

Location

MeSH Terms

Conditions

Thoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: June 25, 2019
• Study Start: November 12, 2019
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

FR (18)