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

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ClinicalTrials.gov Identifier: NCT03943914
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Chest Injuries Respiratory Failure Combination Product: Preventive strategy Combination Product: Standard of care Not Applicable

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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

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. PaO2/FiO2 ratio [ Time Frame: every 6 hours during the first 48 hours after randomization ]
  2. Respiratory rate [ Time Frame: every 6 hours during the first 48 hours after randomization ]
  3. Dyspnea score [ Time Frame: every 6 hours during the first 48 hours after randomization ]
    Dyspnea score : +2 = significant improvement; +1 = slight improvement; 0 = no change; -1 = slight deterioration ; -2 = significant deterioration

  4. ICU and hospital length of stay [ Time Frame: Up to 14 days after randomization ]
  5. ICU or in-hospital mortality [ Time Frame: Up to 14 days after randomization ]
  6. Number of ventilator free-days [ Time Frame: Up to 14 days after randomization ]
    Days alive and without invasive or non-invasive mechanical ventilation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943914


Contacts
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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

Locations
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France
CHU Amiens-Picardie Not yet recruiting
Amiens, France, 80054
Contact: Hervé DUPONT, MD-PhD         
Principal Investigator: Hervé DUPONT, MD-PhD         
CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Cédric CARRIE, MD       cedric.carrie@chu-bordeaux.fr   
Contact: Matthieu BIAIS, MD-PhD       matthieu.biais@chu-bordeaux.fr   
Principal Investigator: Cédric CARRIE, MD         
Sub-Investigator: Matthieu BIAIS, MD-PhD         
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Thomas GODET, MD       tgodet@chu-clermontferrand.fr   
Principal Investigator: Thomas GODET, MD         
APHP - Hôpital Beaujon Not yet recruiting
Clichy, France, 92110
Contact: Igor JURCISIN, MD       igor.jurcisin@aphp.fr   
Principal Investigator: Igor JURCISIN, MD         
CH de Libourne Not yet recruiting
Libourne, France
Contact: Hubert GRAND, Dr       hubert.grand@ch-libourne.fr   
AP-HM - Hôpital de la Timone Not yet recruiting
Marseille, France, 13385
Contact: Marc GAINNIER, MD-PhD       marc.gainnier@ap-hm.fr   
Principal Investigator: Marc GAINNIER, MD-PhD         
CHU de Nice Not yet recruiting
Nice, France, 06001
Contact: Carole ICHAI, MD-PhD       ichai@unice.fr   
Principal Investigator: Carole ICHAI, MD-PhD         
CHU de Nîmes Not yet recruiting
Nîmes, France, 30029
Contact: Laurent MULLER, MD       laurent.muller@chu-nimes.fr   
Principal Investigator: Laurent MULLER, MD         
APHP - Hôpital Tenon Not yet recruiting
Paris 20, France, 75020
Contact: Muriel FARTOUKH, MD-PhD       muriel.fartoukh@aphp.fr   
Principal Investigator: Muriel FARTOUKH, MD-PhD         
CH de Pau Not yet recruiting
Pau, France, 64000
Contact: Alexandre MASSRI, MD       alexandre.massri@ch-pau.fr   
Principal Investigator: Alexandre MASSRI, MD         
HCL - Hôpital Lyon Sud Not yet recruiting
Pierre-Bénite, France, 69495
Contact: Jean-Stéphane DAVID, MD-PhD       jean-stephane.david@chulyon.fr   
Principal Investigator: Jean-Stéphane DAVID, MD-PhD         
CHU de Poitiers Recruiting
Poitiers, France, 86021
Contact: Claire DAHYOT-FIZELIER, MD-PhD       claire.dahyot-fizelier@chu-poitiers.fr   
Principal Investigator: Claire DAHYOT-FIZELIER, MD-PhD         
CHU de Saint Etienne Not yet recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Marie REYNAUD SALARD, MD       marie.reynaud@chu-stetienne.fr   
Principal Investigator: Marie REYNAUD SALARD, MD         
CHU de Strasbourg - Hôpital Civil Not yet recruiting
Strasbourg, France, 67091
Contact: Olivier COLLANGE, MD       olivier.collange@chru-strasbourg.fr   
Principal Investigator: Olivier COLLANGE, MD         
CHU de Strasbourg -Hôpital de Hautepierre Recruiting
Strasbourg, France, 67200
Contact: Julien POTTECHER, MD-PhD       julien.pottecher@chru-strasbourg.fr   
Principal Investigator: Julien POTTECHER, MD-PhD         
Hôpital Robert Picqué Not yet recruiting
Villenave-d'Ornon, France, 33882
Contact: David TRAN-VAN, MD       david.tranvan@intradef.gouv.fr   
Principal Investigator: David TRAN-VAN, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Antoine BENARD, MD Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique (USMR) du CHU de Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03943914    
Other Study ID Numbers: CHUBX 2018/62
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Chest trauma
Respiratory failure
Noninvasive ventilation
High-flow nasal oxygen therapy
Additional relevant MeSH terms:
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Respiratory Insufficiency
Thoracic Injuries
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases