Physiologic Effects of High Flow Nasal Therapy in Patients With Acute Hypoxemic Respiratory Failure (OPTIFLOW)

Respiratory Failure Clinical Trial

Official title:

Physiologic Effects of High Flow Nasal Therapy in Patients With Acute Hypoxemic Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056952
• Other study ID #: CHUBX 2009/15
• Status: Completed
• Phase: N/A
• First received: January 18, 2010
• Last updated: June 13, 2012
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: June 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess, in patients with acute hypoxemic respiratory failure, the short term physiologic effects of the high flow oxygen nasal therapy (Optiflow), in term of inspiratory muscle effort, gas exchange, comfort and dyspnea

Description:

The administration of a known concentration of oxygen is an important part of routine care of the patient admitted in intensive care unit for acute hypoxemic respiratory failure. A new high flow oxygen delivery system (Fisher and Paykel Health care) has been developed (Optiflow). The system used a heated humidifier and heated breathing circuit via a nasal interface. High flow nasal therapy (Optiflow) is associated with the generation of significant positive airway pressure in healthy volunteers. Positive expiratory pressure may have a number of benefits in respiratory failure which include improved ventilation/perfusion matching with improved oxygenation, reduced airways resistance and reduced work of breathing. Moreover high flow nasal therapy may improve oxygen administration by decreasing oxygen dilution, decreasing death space and using high levels of humidification

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute respiratory insufficiency, defined as the PaO2/FIO2 ratio of 300 mm Hg or less after breathing oxygen

• The presence of lung infiltrates on a posteroanterior chest radiograph

Exclusion Criteria:

• Face or cranial trauma or surgery

• Patients younger than 18 years

• History of COPD

• Acute respiratory acidosis (defined as a pH <7.30 and a PaCO2 >50 mm Hg)

• Hemodynamic instability with arterial pressure < 90mmHg

• Respiratory instability with PaO2/FiO2<100mmHg

• ventricular arrhythmias

• Excess respiratory secretions.

• Upper gastrointestinal bleeding

• Recent gastric or oesophageal surgery

• Tracheostomy or other airways disorders

• Pneumothorax

• Contraindication of gastric probe insertion

• Impossibility to insert the oesophageal probe

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• O2stand
Standard low flow oxygen therapy (O2stand). The patients will receive oxygen delivered through a face mask. The FiO2 will be adjusted in order to obtain a SaO2 > 90%. The FiO2 will be determined by a portable oxygen analyzer (MiniOX I; Mine Safety Appliances Co, Pittsburgh, Pa)
• CPAP
o Continuous positive airway pressure (CPAP). CPAP will be set at 7.5 cmH2O. Airway humidification will be achieved by using a heated humidifier (MR640; Fisher & Paykel, Auckland, NZ). The FiO2 will be adjusted in order to obtain a SaO2 > 90%. A facial mask composed of a transparent mask and a soft inflatable will be used
• Optiflow
High flow oxygen nasal therapy (Optiflow). The flow will be set at 40l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SaO2 > 90%

Locations

Country	Name	City	State
France	Pellegrin Hospital, Recovery Unit	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes)		Every 30 minutes for 90 minutes	No
Secondary	Gas exchange :PaO2/FiO2 ratio		Every 30 minutes for 90 minutes	No
Secondary	Comfort assessed using a five-item semi quantitative scale		Every 30 minutes for 90 minutes	No
Secondary	Dyspnea assessed using a visual analogic scale		Every 30 minutes for 90 minutes	No