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Study about the high flow and conventional oxigen therapy in patients with severe acute respiratory failure.

A phase IV randomized, controlled clinical trial to compare the high flow oxygen therapy (group of intervention) opposite to the conventional oxygen therapy (group control) in patients with severe acute respiratory failure. - High flow and conventional oxigen therapy in patients with severe acute respiratory failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001671-36-ES
Enrollment
Unknown
Registered
2012-06-25
Start date
2012-08-27
Completion date
Unknown
Last updated
2016-01-25

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

Conditions

Severe acute respiratory failure

Interventions

Trade Name: Oxígeno medicinal líquido carburos metálicos, gas para inhalación 99,5% en tanques. Product Name: Oxígeno medicinal Product Code: 66969 Pharmaceutical Form: Inhalation gas Current Sponsor

Sponsors

Fundación para la Investigación Biomédica
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ?Patients of both major sexes of 18 years joined UCI. ?severe acute respiratory failure defined clinical for: peripheral Saturation of oxygen (SatO2p by means of pulsioximetria) =65 years) yes F.1.3.1 Number of subjects for this age range 95

Exclusion criteria

Exclusion criteria: ?Glasgow <11 ? Need of urgent intubation ?sharp Agitation without collaboration of the patient ? Shock with instability hemodinámica that does not answer to volume and aminas vasoactivas. ? Any patient who to criterion of the investigator could not expire with the specifications of the protocol

Design outcomes

Primary

MeasureTime frame
Main Objective: 1. To Evaluate if the high flow oxigen therapy with warm system of humidificación by means of nasal glasses (optiflow) opposite to the conventional oxygen therapy like treatment of the severe acute respiratory failure of any etiology determines a minor need of intubation orotraqueal. 2. To evaluate if the system optiflow provides a better tolerance and comfort of the patient with severe acute respiratory failure that needs oxygen therapy to high concentrations of oxygen.;Secondary Objective: To evaluate if there exist variables of the clinical initial situation and of the clinical evolution and / or gasométrica of the first 24 hours after the recruitment, which they could endure as predictive factors of intubation orotraqueal in these patients.;Primary end point(s): 1.Need of intubation orotraqueal 2. Tolerance and comfort on the utilization of the devices of oxygen therapy.;Timepoint(s) of evaluation of this end point: Need of intubation orotraqueal (hours up to the intubation, days of intubation),Parameters: ' Respiratory (respiratory frequency, SatO2p), ' Gasométricos (pH, pO2, pCO2 and balance acid - base) Tolerance and comfort on the utilization of the devices of oxygen therapy

Secondary

MeasureTime frame
Secondary end point(s): Exitus, Infection nosocomial, Pneumonia, days of stay in UCI and in the hospital;Timepoint(s) of evaluation of this end point: exitus, Infection nosocomial, Pneumonia, days of stay in UCI and in the hospital

Countries

Spain

Contacts

Public ContactDpto.EECC, Rafael Fernandez

Fundación para la Investigación Biomédica

eecc.fib.hlpr@salud.madrid.org3491520.24.76

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026