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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02633-40 | Registry Identifier | National Agency for the Safety of Medicines and Health Products |
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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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The purpose of this study is to determine whether nasal high flow is non inferior to non invasive ventilation (NIV) in the early treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and hypercapnic acidosis in the emergency department (ED). After obtaining informed consent, participants will be randomly assigned to receive either nasal high flow or non invasive ventilation (NIV, reference treatment) as respiratory support. Researchers will compare both respiratory support groups to see if their blood gas analysis and respiration return to normal ranges.
Prospective multicenter comparative therapeutic study, with a randomized controlled parallel and open design. Nasal high flow will be compared to NIV (reference treatment) for early treatment of AE-COPD associated with hypercapnic acidosis.
Adult patients admitted to the ED for AE-COPD with hypercapnic acidosis will be randomized to receive either nasal high flow or NIV as ventilatory support. Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment. Close monitoring of clinical and gas parameters will be conducted with repeat assessment and serial blood gas testing at 2h and after each 2h session of respiratory support in the ED (2h, 4h, 6h) and at 24h.
Standard oxygen therapy will be administered as required between ventilatory support sessions to maintain a target peripheral oxygen saturation (SpO2 : 88-92%).
Patient's dyspnea and comfort will be assessed before treatment and at 2h, and after each respiratory support session in the ED Patients will receive standard medical treatment for AE-COPD (bronchodilator, corticosteroids and antibiotics) according to current practice and 2023 global initiative guidelines for the management of COPD (GOLD).
Patients will be followed up at day 28 by means of medical records review and telephone interview
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal high flow | Experimental | Nasal high flow will be administered through a heated humidifier (Airvo 3, Fisher and Paykel healthcare) and applied through large bore binasal prongs. Initial gas flow rate will be set at 60 l/min, FiO2 will be adjusted to maintain an SpO2 88-92% and Initial temperature will be set at 37° and reduced according to patient's tolerance. Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment |
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| Non invasive ventilation | Active Comparator | NIV will be delivered through a face mask connected to a ventilator with pressure support applied in a noninvasive ventilation mode. The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 88-92% and to patient's comfort. Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventilatory support via nasal high flow | Device | Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PaCO2 | PaCO2 will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory assistance and after 2 hours of treatment | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pH | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory support and after 2 hours of treatment | 2 hours |
| Change in PaO2 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization rate, including hospitalization in critical care units | Proportion of patients requiring hospitalization following ED management | Day 28 |
| Readmission for AE-COPD | Proportion of patients requiring emergency department admission for AE-COPD within 28 days from index admission |
Adult Patient admitted to the ED for acute exacerbation of COPD (AE-COPD)and respiratory acidosis (PaCO2 > 45 mmHg and pH <7.35), for whom ventilatory assistance by NIV is indicated (SPLF 2017, GOLD2023 recommendations)
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustapha Sebbane, MD, PhD | Contact | +33 (4) 67 33 85 76 | m-sebbane@chu-montpellier.fr | |
| Sophie LEFEBVRE, PhD | Contact | +33 (4) 67 33 85 76 | s-lefebvre@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mustapha Sebbane, MD, PhD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier University Hospital | Recruiting | Montpellier | Montepllier | 34000 | France |
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Participants are randomly assigned to either one of two groups of respiratory support (NIV or nasal high flow) in parallel. Randomization will be in a 1:1 ratio, and stratified by center, severity of hypercapnia and acidosis
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Masking non feasible
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| Ventilatory support via NIV | Device | Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment. |
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Blood gas parameters will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory support and after 2 hours of treatment
| 2 hours |
| Change in PaCO2 | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory support and after sessions of ventilatory support | up to 24 hours |
| Change in pH | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory support and after sessions of ventilatory support | up to 24 hours |
| Change in PaO2 | Blood gas parameters will be measured from standard laboratory arterial blood gas analysis before the initiation of ventilatory support and after sessions of ventilatory support | up to 24 hours |
| Respiratory rate | Clinical parameters will be monitored by physician at baseline and throughout ventilatory support sessions, according to the international guidelines for NIV monitoring | up to 24 hours |
| Signs of increased work of breathing (use of accessory respiratory muscles, paradoxical motion of the abdomen) | Use of accessory respiratory muscles and paradoxical motion of the abdomen will be assessed by physician at baseline and after sessions of ventilatory support, on a 5 point likert scale (from 1 : absence to 5 : maximal use or accessory respiratory muscle and paradoxical motion of the abdomen) | up to 24 hours |
| Perceived dyspnea | Dyspnea will be assessed by the patient using a Modified Borg scale for dyspnea, at baseline and after sessions of ventilatory support. Difficulty of breathing will be quantified on a scale from 0 : no difficulty at all to 10 : breathing difficulty is maximal. | up to 24 hours |
| Treatment failure (composite of change of treatment arm / need for invasive mechanical ventilation/ mortality) | Failure will be defined by a composite of clinical or gasometric worsening or patient intolerance inducing a change of treatment arm/ need for orotracheal intubation and/or mortality (all causes). | Up to Day 28 |
| Weaning from ventilatory support | Delay from initiation of ventilatory support to weaning | Up to Day 28 |
| Day 28 |
| Centre hospitalier universitaire de Nimes | Not yet recruiting | Nîmes | France |
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| Centre Hospitalier Universitaire de Poitiers | Not yet recruiting | Poitiers | France |
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| ID | Term |
|---|---|
| D000142 | Acidosis, Respiratory |
| D012131 | Respiratory Insufficiency |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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