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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00532-55 | Other Identifier | ANSM |
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In blunt chest trauma patients without immediate life-threatening conditions, delayed respiratory failure and need for mechanical ventilation may still occur in 12 to 40% of patients, depending on the severity of the trauma, the preexisting conditions and the intensity of initial management.
In this context, non-invasive ventilation (NIV) is recommended in hypoxemic chest trauma patients, defined as a PaO2/FiO2 ratio < 200 mmHg. However, there is a large heterogeneity among studies regarding the severity of injuries, the degree of hypoxemia and the timing of enrollment. The interest of a preventive strategy during the early phase of blunt chest trauma, before the occurrence of respiratory distress or severe hypoxemia, is not formally established in the literature. Moreover, high-flow nasal oxygen therapy (HFNC-O2) appears to be a reliable and better tolerated alternative to conventional oxygen therapy (COT), associated with a significant reduction in intubation rate in hypoxemic patients.
Two NIV strategies are compared:
Investigators hypothesized that an early strategy associating HFNC-O2 and preventive NIV in hypoxemic blunt chest trauma patients may reduce the need for mechanical ventilation compared to the recommended strategy associating COT and late NIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| An "early" NIV strategy associated with HFNC-O2 | Experimental |
| |
| A "late" NIV strategy associated with COT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preventive strategy | Combination Product | In the experimental strategy, NIV is performed after inclusion in patients with moderate hypoxemia, defined by a PaO2/FiO2 ratio < 300 mmHg. The minimally required duration of NIV was 4 hours per day for at least 2 calendar days. The daily duration of NIV can be increased at the discretion of the physician in patients with signs of delayed respiratory failure under HFNC-O2 and improving under NIV. Beyond the first 48 hours, NIV and HFNC-O2 can be stopped and the patient switched to COT if respiratory rate < 25/min and SpO2 > 92% under FiO2 < 30% for at least 6 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Necessity to perform endotracheal intubation | To ensure the consistency of indications across sites and reduce the risk of delayed intubation, the following criteria for endotracheal intubation must be used (only one criterion is needed): cardiac arrest or significant hemodynamic instability, deterioration of neurologic status, signs of persisting or worsening respiratory failure as defined by at least two of the following criteria: respiratory rate of more than 35 breaths per minute, lack of improvement in signs of high respiratory-muscle workload, development of copious tracheal secretions, signs of respiratory exhaustion (pH <7.32 or PaCO2 > 50 mmHg), major hypoxemia (PaO2/FiO2 ratio <100 or SpO2 <92% for more than 5 minutes). | Up to 14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| PaO2/FiO2 ratio | every 6 hours during the first 48 hours after randomization | |
| Respiratory rate | every 6 hours during the first 48 hours after randomization | |
| Dyspnea score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine BENARD, MD | Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Amiens | 80054 | France | |||
| CH d'Annecy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37101272 | Result | Carrie C, Rieu B, Benard A, Trin K, Petit L, Massri A, Jurcison I, Rousseau G, Tran Van D, Reynaud Salard M, Bourenne J, Levrat A, Muller L, Marie D, Dahyot-Fizelier C, Pottecher J, David JS, Godet T, Biais M. Early non-invasive ventilation and high-flow nasal oxygen therapy for preventing endotracheal intubation in hypoxemic blunt chest trauma patients: the OptiTHO randomized trial. Crit Care. 2023 Apr 26;27(1):163. doi: 10.1186/s13054-023-04429-2. |
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|
| Standard of care | Combination Product | In the control group, patients receive oxygen from nasal cannula or high concentration oxygen mask according to the FiO2 needed to achieve SpO2 > 92%. NIV is initiated only in patients having PaO2/FiO2 ratio < 200 mmHg under COT. A trial of curative NIV is allowed at the discretion of the physician in patients who have signs of delayed respiratory failure and no other organ dysfunction. The non-improvement of respiratory conditions after 1 hour of NIV, the NIV-dependence (≥ 12 consecutive hours) or NIV-intolerance should be considered as criteria for endotracheal intubation. |
|
Dyspnea score : +2 = significant improvement; +1 = slight improvement; 0 = no change; -1 = slight deterioration ; -2 = significant deterioration |
| every 6 hours during the first 48 hours after randomization |
| ICU and hospital length of stay | Up to 14 days after randomization |
| ICU or in-hospital mortality | Up to 14 days after randomization |
| Number of ventilator free-days | Days alive and without invasive or non-invasive mechanical ventilation | Up to 14 days after randomization |
| Annecy |
| France |
| CHU de Bordeaux | Bordeaux | 33076 | France |
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| APHP - Hôpital Beaujon | Clichy | 92110 | France |
| AP-HM - Hôpital de la Timone | Marseille | 13385 | France |
| CHU de Nîmes | Nîmes | 30029 | France |
| CH de Pau | Pau | 64000 | France |
| HCL - Hôpital Lyon Sud | Pierre-Bénite | 69495 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| CHU de Saint Etienne | Saint-Priest-en-Jarez | 42270 | France |
| CHU de Strasbourg - Hôpital Civil | Strasbourg | 67091 | France |
| CHU de Strasbourg -Hôpital de Hautepierre | Strasbourg | 67200 | France |
| Hôpital Robert Picqué | Villenave-d'Ornon | 33882 | France |
| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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