Which Place for High Flow Oxygen in ICU ?

Hypoxemia Clinical Trial

Official title:

Which Place for High Flow Oxygen in Intensive Care Unit ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080208
• Other study ID #: OptSCM
• Status: Completed
• Phase: N/A
• First received: January 9, 2014
• Last updated: January 29, 2016
• Start date: February 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who need only oxygen support, usually received low flow oxygen (< 15 Liters / min), as well as in respiratory weaning. Now new devices can be used. They provide high flow oxygen with different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2), allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of this study is that the high flow oxygen enable more efficient oxygen administration than conventional oxygen. In addition, it would improve the effectiveness of the ventilation of the patient, through flushing the dead space.

Description:

The investigators hypothesized that when using high flow oxygen therapy, respiratory failure is relieved, as well as ventilation failure, so accessories are less stressed muscles, and this can be demonstrated by the electromyography (EMG) of sterno-mastoid..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria: patients with respiratory failure.

• Spontaneously breathing patient requiring administration at least 40% oxygen, or,

• Patient under mechanical ventilation, during respiratory weaning.

Exclusion Criteria:

• Facial trauma, active hemoptysis, pneumothorax, thoraco-abdominal surgery or upcoming intubation for spontaneously breathing patients.

• Neuromuscular disease, altered consciousness or agitation for patients under mechanical ventilation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypoxemia

Intervention

Device:
• Optiflow
patients receive oxygen via high flow oxygen therapy during 20 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from baseline in hemodynamic criteria	cardiac frequency, arterial blood pressure	20 minutes	Yes
Primary	Change from baseline in Oxygenation criteria	Arterial oxygen partial pressure (PO2), oxygen saturation by pulse oximetry (SpO2), arterial PO2/FiO2, positive end expiratory pressure (PEEP)	20 minutes	No
Secondary	Change from baseline in Ventilation criteria	respiratory rate (RR), arterial partial CO2 pressure (PCO2), pH, sterno-mastoid EMG	20 minutes	No