Clinical trial NCT03943914: Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.
Official title: Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Injuries
Respiratory Failure
Keywords: Chest trauma
Respiratory failure
Noninvasive ventilation
High-flow nasal oxygen therapy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Necessity to perform endotracheal intubation
timeFrame: Up to 14 days after randomization
Secondary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: every 6 hours during the first 48 hours after randomization
measure: Respiratory rate
timeFrame: every 6 hours during the first 48 hours after randomization
measure: Dyspnea score
timeFrame: every 6 hours during the first 48 hours after randomization
measure: ICU and hospital length of stay
timeFrame: Up to 14 days after randomization
measure: ICU or in-hospital mortality
timeFrame: Up to 14 days after randomization
measure: Number of ventilator free-days
timeFrame: Up to 14 days after randomization
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Annecy
country: France
facility: CH d'Annecy
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Clichy
country: France
facility: APHP - Hôpital Beaujon
city: Marseille
country: France
facility: AP-HM - Hôpital de la Timone
city: Nîmes
country: France
facility: CHU de Nîmes
city: Pau
country: France
facility: CH de Pau
city: Pierre-Bénite
country: France
facility: HCL - Hôpital Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital Civil
city: Strasbourg
country: France
facility: CHU de Strasbourg -Hôpital de Hautepierre
city: Villenave-d'Ornon
country: France
facility: Hôpital Robert Picqué
Study officials:
affiliation: Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
References: