High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— OPTINEB  

Official title:

High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03449056
• Other study ID #: OPTINEB
• Status: Recruiting
• Phase: Phase 3
• Start date: January 11, 2019
• Est. completion date: April 2020

Study information

• Verified date: February 2019
• Source: Poitiers University Hospital
• Contact: Jean-Pierre FRAT
• Phone: +33549442830
• Email: jean-pierre.frat[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High-flow nasal cannula is an oxygenation technique increasingly used for patients admitted for acute respiratory failure. Literature essentially concerns "de novo" acute hypoxemic failure and the interest of high-flow during take care of chronic obstructive pulmonary disease patients is few studied. Physiological studies reported potential benefits of high-flow nasal cannula oxygenation in chronic obstructive pulmonary disease patients including dead space clearance and decrease of respiratory, which lead to decrease work of breathing. As inhaled bronchodilators are part of treatment of chronic obstructive pulmonary disease exacerbation, nebulization could be also provided through high-flow nasal cannula oxygen therapy. The aim of our study is to determine whether a beta-2 agonist nebulization administered through High-flow nasal cannula is efficient to improve spirometry of patients for admitted hronic obstructive pulmonary disease exacerbation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Arterial pH over 7.25,

• Respiratory rate under 35 breaths/mn

• Glasgow Coma Scale equal to 15,

• indication of beta-2 agonist nebulization less than 8 per day (time between two nebulization more than 3 hours),

• NIV sessions spaced more than 6 hours.

Exclusion Criteria:

• Urgent endotracheal intubation;

• Contraindication to beta 2 adrenergic agonist;

• Another organ failure (hemodynamic and neurological instability);

• Cardioselective beta-blocker during treatment of copd exacerbation;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• High-flow Nasal Cannula
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• salbutamol
T2 - T1+1h30: High-nasal flow and salbutamol nebulization

Locations

Country	Name	City	State
France	C.H.U. de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare lung functions	Evolution of Forced Expiratory Volume 1s	baseline-1h30