Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study

Acute Respiratory Failure Clinical Trial

Official title:

Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447457
• Other study ID #: FLORAL-ER
• Status: Completed
• Phase: N/A
• First received: February 19, 2018
• Last updated: February 26, 2018
• Start date: December 1, 2015
• Est. completion date: May 30, 2017

Study information

• Verified date: February 2018
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the efficiency on respiratory failure regression of high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ED for de novo acute respiratory failure.

Description:

Prospective observational before-after study at the ED in two French centers.

Selection of patients with acute hypoxemic respiratory failure at the ED.

Application of oxygen strategy according to the period:

• before period: standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir mask, with a flow rate adjusted to maintain a pulse oxymetry of at least 92%.

• after period: high-flow oxygen therapy continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• de novo acute respiratory failure cowith the following criteria: a respiratory rate > 25 b/min, or signs of increased work of breathing.

Main exclusion Criteria:

• cardiogenic pulmonary edema,

• acute exacerbation of chronic lung disease, respiratory acidosis (pH < 7.35 and PaCO2 > 50 mm Hg),

• hemodynamic instability

• Glasgow Coma Scale score of 12 points or less,

• an urgent need for endotracheal intubation,

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Emergencies
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• High-flow oxygen
HFNC is continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%
• Standard oxygen
nasal cannula, face mask or non-rebreathing reservoir mask

Locations

Country	Name	City	State
France	CHG de Niort	Niort
France	CHU Poitiers	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	CHG de Niort, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete regression of respiratory failure	respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing	one hour after initiation of oxygen strategies