Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.

NACompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

September 25, 2019

Primary Completion Date

November 9, 2021

Study Completion Date

November 9, 2021

Conditions
Chest InjuriesRespiratory Failure
Interventions
COMBINATION_PRODUCT

Preventive 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_PRODUCT

Standard 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.

Trial Locations (14)

13385

AP-HM - Hôpital de la Timone, Marseille

30029

CHU de Nîmes, Nîmes

33076

CHU de Bordeaux, Bordeaux

33882

Hôpital Robert Picqué, Villenave-d'Ornon

42270

CHU de Saint Etienne, Saint-Priest-en-Jarez

63003

CHU de Clermont-Ferrand, Clermont-Ferrand

64000

CH de Pau, Pau

67091

CHU de Strasbourg - Hôpital Civil, Strasbourg

67200

CHU de Strasbourg -Hôpital de Hautepierre, Strasbourg

69495

HCL - Hôpital Lyon Sud, Pierre-Bénite

80054

CHU Amiens-Picardie, Amiens

86021

CHU de Poitiers, Poitiers

92110

APHP - Hôpital Beaujon, Clichy

Unknown

CH d'Annecy, Annecy

All Listed Sponsors
lead

University Hospital, Bordeaux

OTHER

NCT03943914 - Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients. | Biotech Hunter | Biotech Hunter