Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Clinical Trial

— HiCOPD  

Official title:

Nasal High Flow in Early Management of Patients Admitted to the Emergency Department for Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis : a Randomized Controlled Non Inferiority Study

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
• 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
• 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

Related Conditions & MeSH terms

• Acidosis
• Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Hypercapnic Acidosis
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Failure With Hypercapnia
• Respiratory Insufficiency

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