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:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chest Injuries Respiratory Failure | Combination Product: Preventive strategy Combination Product: Standard of care | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 278 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients. |
| Actual Study Start Date : | September 25, 2019 |
| Estimated Primary Completion Date : | October 2021 |
| Estimated Study Completion Date : | October 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: An "early" NIV strategy associated with HFNC-O2 |
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.
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| Active Comparator: A "late" NIV strategy associated with COT |
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Matthieu BIAIS, MD-PhD | 05 57 82 10 19 ext +33 | matthieu.biais@chu-bordeaux.fr | |
| Contact: Cédric CARRIE, MD | 05 56 79 55 95 ext +33 | cedric.carrie@chu-bordeaux.fr |
Show 17 study locations
| Study Chair: | Antoine BENARD, MD | Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||||||
| First Posted Date ICMJE | May 9, 2019 | ||||||||
| Last Update Posted Date | June 2, 2021 | ||||||||
| Actual Study Start Date ICMJE | September 25, 2019 | ||||||||
| Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Necessity to perform endotracheal intubation [ Time Frame: 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).
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients. | ||||||||
| Official Title ICMJE | Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients. | ||||||||
| 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:
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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
278 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | October 2021 | ||||||||
| Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03943914 | ||||||||
| Other Study ID Numbers ICMJE | CHUBX 2018/62 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University Hospital, Bordeaux | ||||||||
| Study Sponsor ICMJE | University Hospital, Bordeaux | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Bordeaux | ||||||||
| Verification Date | June 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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