Chest Injuries, Respiratory Failure
Conditions
Keywords
Chest trauma, Respiratory failure, Noninvasive ventilation, High-flow nasal oxygen therapy
Brief summary
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: 1. 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. 2. 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. 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.
Interventions
COMBINATION_PRODUCTPreventive strategy
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.
COMBINATION_PRODUCTStandard of care
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.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient admitted in intensive care unit within 48 hours after a high-risk blunt chest trauma, defined by a TTS (Thorax Trauma Severity) score ≥ 8. * Hypoxemia defined by a PaO2/FiO2 ratio \< 300, and the absence of hypercapnia (PaCO2 \< 45 mmHg). * Without indication of endotracheal intubation at inclusion. * Affiliated person or beneficiary of a social security scheme. * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion criteria
* Criteria relating to formal indication to NIV: Exacerbation of underlying chronic respiratory disease, cardiogenic pulmonary edema, severe neutropenia. * Criteria relating to contraindications to NIV: Hemodynamic instability, Glasgow Coma Scale score ≤ 12 or excessive agitation, or other contraindications to non-invasive ventilation (active gastrointestinal bleeding, low level of consciousness, multiorgan failure, airway patency problems, lack of cooperation or hemodynamic instability). * Associated traumatic lesions entailing particular risks: severe brain injury, complex facial trauma, tetraplegia, tracheobronchial or esophageal injuries, thoracic or abdominal trauma with indication for surgery by thoracotomy or laparotomy. * Criteria relating to the regulation: A do-not-intubate order and a decision not to participate, persons placed under judicial protection, persons participating in another research including a period of exclusion still in course, severely altered physical and/or psychological health which, according to the investigator, could affect the participant's compliance of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Necessity to perform endotracheal intubation | Up to 14 days after randomization | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | every 6 hours during the first 48 hours after randomization | Dyspnea score : +2 = significant improvement; +1 = slight improvement; 0 = no change; -1 = slight deterioration ; -2 = significant deterioration |
| 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 | Up to 14 days after randomization | Days alive and without invasive or non-invasive mechanical ventilation |
Countries
France
Contacts
STUDY_CHAIRAntoine BENARD, MD
Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
Outcome results
None listed