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

Respiratory Failure Clinical Trial

— OptiTHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943914
• Other study ID #: CHUBX 2018/62
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: November 9, 2021

Study information

• Verified date: January 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: November 9, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chest Injuries
• Respiratory Failure
• Respiratory Insufficiency
• Thoracic Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens
France	CH d'Annecy	Annecy
France	CHU de Bordeaux	Bordeaux
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	APHP - Hôpital Beaujon	Clichy
France	AP-HM - Hôpital de la Timone	Marseille
France	CHU de Nîmes	Nîmes
France	CH de Pau	Pau
France	HCL - Hôpital Lyon Sud	Pierre-Bénite
France	CHU de Poitiers	Poitiers
France	CHU de Saint Etienne	Saint-Priest-en-Jarez
France	CHU de Strasbourg - Hôpital Civil	Strasbourg
France	CHU de Strasbourg -Hôpital de Hautepierre	Strasbourg
France	Hôpital Robert Picqué	Villenave-d'Ornon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	PaO2/FiO2 ratio		every 6 hours during the first 48 hours after randomization
Secondary	Respiratory rate		every 6 hours during the first 48 hours after randomization
Secondary	Dyspnea score	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
Secondary	ICU and hospital length of stay		Up to 14 days after randomization
Secondary	ICU or in-hospital mortality		Up to 14 days after randomization
Secondary	Number of ventilator free-days	Days alive and without invasive or non-invasive mechanical ventilation	Up to 14 days after randomization