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

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Procedure: O2stand; Procedure: CPAP; Procedure: Optiflow

• Registration Number: NCT01056952
• Lead Sponsor: University Hospital, Bordeaux

Brief 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

Detailed 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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Optiflow then CPAP	O2stand	Standard low flow oxygen therapy then High flow oxygen nasal therapy (Optiflow)then Continuous positive airway pressure (CPAP)
Optiflow then CPAP	CPAP	Standard low flow oxygen therapy then High flow oxygen nasal therapy (Optiflow)then Continuous positive airway pressure (CPAP)
Optiflow then CPAP	Optiflow	Standard low flow oxygen therapy then High flow oxygen nasal therapy (Optiflow)then Continuous positive airway pressure (CPAP)
CPAP then Optiflow	O2stand	Standard low flow oxygen therapy then Continuous positive airway pressure (CPAP)then High flow oxygen nasal therapy (Optiflow)
CPAP then Optiflow	CPAP	Standard low flow oxygen therapy then Continuous positive airway pressure (CPAP)then High flow oxygen nasal therapy (Optiflow)
CPAP then Optiflow	Optiflow	Standard low flow oxygen therapy then Continuous positive airway pressure (CPAP)then High flow oxygen nasal therapy (Optiflow)

Primary Outcome Measures

Name	Time	Method
Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes)	Every 30 minutes for 90 minutes

Secondary Outcome Measures

Name	Time	Method
Gas exchange :PaO2/FiO2 ratio	Every 30 minutes for 90 minutes
Comfort assessed using a five-item semi quantitative scale	Every 30 minutes for 90 minutes
Dyspnea assessed using a visual analogic scale	Every 30 minutes for 90 minutes

Trial Locations

Locations (1)

Pellegrin Hospital, Recovery Unit; 🇫🇷 Bordeaux, France