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

NCT03943914 | Completed

• 1 other identifier: CHUBX 2018/62
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 14

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. 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. 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.

Conditions

Chest Injuries; Respiratory Failure

Keywords

Chest trauma; Respiratory failure; Noninvasive ventilation; High-flow nasal oxygen therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• ICU and hospital length of stay

  Up to 14 days after randomization

• ICU or in-hospital mortality

  Up to 14 days after randomization

Study Arms (2)

An "early" NIV strategy associated with HFNC-O2

EXPERIMENTAL

Combination Product: Preventive strategy

A "late" NIV strategy associated with COT

ACTIVE COMPARATOR

Combination Product: Standard of care

Interventions

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.

An "early" NIV strategy associated with HFNC-O2

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.

A "late" NIV strategy associated with COT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Affiliated person or beneficiary of a social security scheme.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (14)

CHU Amiens-Picardie

Amiens, 80054, France

Location

CH d'Annecy

Annecy, France

Location

CHU de Bordeaux

Bordeaux, 33076, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

APHP - Hôpital Beaujon

Clichy, 92110, France

Location

AP-HM - Hôpital de la Timone

Marseille, 13385, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

CH de Pau

Pau, 64000, France

Location

HCL - Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHU de Saint Etienne

Saint-Priest-en-Jarez, 42270, France

Location

CHU de Strasbourg - Hôpital Civil

Strasbourg, 67091, France

Location

CHU de Strasbourg -Hôpital de Hautepierre

Strasbourg, 67200, France

Location

Hôpital Robert Picqué

Villenave-d'Ornon, 33882, France

Location

MeSH Terms

Conditions

Thoracic Injuries; Respiratory Insufficiency

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Antoine BENARD, MD

  Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: September 25, 2019
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)