NCT01056952

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

January 18, 2010

Last Update Submit

June 13, 2012

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

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

    Every 30 minutes for 90 minutes

Secondary Outcomes (3)

  • 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

Study Arms (2)

Optiflow then CPAP

EXPERIMENTAL

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

Procedure: O2standProcedure: CPAPProcedure: Optiflow

CPAP then Optiflow

EXPERIMENTAL

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

Procedure: O2standProcedure: CPAPProcedure: Optiflow

Interventions

O2standPROCEDURE

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 then OptiflowOptiflow then CPAP
CPAPPROCEDURE

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

CPAP then OptiflowOptiflow then CPAP
OptiflowPROCEDURE

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%

CPAP then OptiflowOptiflow then CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pellegrin Hospital, Recovery Unit

Bordeaux, 33076, France

Location

Related Publications (1)

  • 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.

    PMID: 25944940DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Frédéric VARGAS, MD

    University Hospital, Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2010

First Posted

January 26, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

FR(1)