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Completed

NCT Number: NCT01056952

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pellegrin Hospital, Recovery Unit

Bordeaux, 33076, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

O2stand

Procedure

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

Procedure

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

Procedure

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%

Primary outcomes

  1. Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes)

    Time frame: Every 30 minutes for 90 minutes

Secondary outcomes

  1. Gas exchange :PaO2/FiO2 ratio

    Time frame: Every 30 minutes for 90 minutes

  2. Comfort assessed using a five-item semi quantitative scale

    Time frame: Every 30 minutes for 90 minutes

  3. Dyspnea assessed using a visual analogic scale

    Time frame: Every 30 minutes for 90 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 26, 2010
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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