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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06114667
Other study ID # RECHMPL19_0626
Secondary ID 2022-A02633-40
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date June 30, 2026

Study information

Verified date August 2023
Source University Hospital, Montpellier
Contact Mustapha Sebbane, MD, PhD
Phone +33 (4) 67 33 85 76
Email m-sebbane@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 174
Est. completion date June 30, 2026
Est. primary completion date May 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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: - Patients with ability to understand and give an informed consent - Patients affiliated with or who benefit from a social security - Patients admitted to the emergency department for a clinical suspicion of AE-COPD based on clinical history, physical examination and chest X-ray (SPLF 2017) - Patients with acute respiratory failure defined by: Respiratory rate = 25 bpm AND/OR Signs of respiratory failure (use of accessory respiratory muscles, paradoxical abdominal movement) - Patients with respiratory acidosis defined by PaCO2 > 45 mmHg AND pH < 7.35 (measured on arterial blood gas) Exclusion Criteria: - Patients who have already received NIV treatment before inclusion (including in-hospital or prehospital, with the exception of NIV at home) - Contraindication to non-invasive ventilation (SPLF 2017 and GOLD 2023 recommendations) - Patient uncooperative, agitated, opponent of the technique

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ventilatory support via nasal high flow
Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.
Ventilatory support via NIV
Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.

Locations

Country Name City State
France Centre hospitalier universitaire de Montpellier Montpellier
France Centre hospitalier universitaire de Nimes Nimes
France Centre Hospitalier Universitaire de Poitiers Poitiers

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Montpellier Fisher and Paykel Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Hospitalization rate, including hospitalization in critical care units Proportion of patients requiring hospitalization following ED management Day 28
Other Readmission for AE-COPD Proportion of patients requiring emergency department admission for AE-COPD within 28 days from index admission Day 28
Primary 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
Secondary 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
Secondary Change in PaO2 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Weaning from ventilatory support Delay from initiation of ventilatory support to weaning Up to Day 28
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