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

February 11, 2019 updated by: Poitiers University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Poitiers, France, 86000
        • Recruiting
        • C.H.U. de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TREATMENT
salbutamol nebulization
Drug: salbutamol
T2 - T1+1h30: High-nasal flow and salbutamol nebulization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare lung functions
Time Frame: baseline-1h30
Evolution of Forced Expiratory Volume 1s
baseline-1h30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 11, 2019

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

April 1, 2020

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (ACTUAL)

February 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTINEB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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