Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01056952
Enrollment
12
Registered
2010-01-26
Start date
2010-01-31
Completion date
2012-01-31
Last updated
2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

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

Interventions

PROCEDUREO2stand

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)

PROCEDURECPAP

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

PROCEDUREOptiflow

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%

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes)Every 30 minutes for 90 minutes

Secondary

MeasureTime frame
Gas exchange :PaO2/FiO2 ratioEvery 30 minutes for 90 minutes
Comfort assessed using a five-item semi quantitative scaleEvery 30 minutes for 90 minutes
Dyspnea assessed using a visual analogic scaleEvery 30 minutes for 90 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026