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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
O2stand
CPAP
Optiflow
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pellegrin Hospital, Recovery Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Optiflow then CPAP

CPAP then Optiflow

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Gas exchange :PaO2/FiO2 ratio
Comfort assessed using a five-item semi quantitative scale
Dyspnea assessed using a visual analogic scale

Full Information

First Posted
January 18, 2010
Last Updated
June 13, 2012
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01056952
Brief Title
Physiologic Effects of High Flow Nasal Therapy in Patients With Acute Hypoxemic Respiratory Failure (OPTIFLOW)
Official Title
Physiologic Effects of High Flow Nasal Therapy in Patients With Acute Hypoxemic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optiflow then CPAP
Arm Type
Experimental
Arm Description
Standard low flow oxygen therapy then High flow oxygen nasal therapy (Optiflow)then Continuous positive airway pressure (CPAP)
Arm Title
CPAP then Optiflow
Arm Type
Experimental
Arm Description
Standard low flow oxygen therapy then Continuous positive airway pressure (CPAP)then High flow oxygen nasal therapy (Optiflow)
Intervention Type
Procedure
Intervention Name(s)
O2stand
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
CPAP
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Optiflow
Intervention Description
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 Outcome Measure Information:
Title
Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes)
Time Frame
Every 30 minutes for 90 minutes
Secondary Outcome Measure Information:
Title
Gas exchange :PaO2/FiO2 ratio
Time Frame
Every 30 minutes for 90 minutes
Title
Comfort assessed using a five-item semi quantitative scale
Time Frame
Every 30 minutes for 90 minutes
Title
Dyspnea assessed using a visual analogic scale
Time Frame
Every 30 minutes for 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric VARGAS, MD
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pellegrin Hospital, Recovery Unit
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25944940
Citation
Vargas F, Saint-Leger M, Boyer A, Bui NH, Hilbert G. Physiologic Effects of High-Flow Nasal Cannula Oxygen in Critical Care Subjects. Respir Care. 2015 Oct;60(10):1369-76. doi: 10.4187/respcare.03814. Epub 2015 May 5.
Results Reference
derived

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

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