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Respiratory Failure | Extubation Failure Prevention in High Risk Patients by High-flow Conditioned Oxygen Therapy vs. Standard Oxygen Therapy

Respiratory Failure research study

What is the primary objective of this study?

Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of breathing. Most of this issues can be partly counterbalanced by a device named \"High flow conditioned oxygen therapy (HFCO)\". Then, our hypothesis is that HFCO may reduce the incidence of respiratory failure after extubation in patients with high risk for failure.

Who is eligible to participate?

Inclusion Criteria: - Patients mechanically ventilated for > 48 hours and at least one of the following: - >65 years - cardiac failure as the primary indication of mechanical ventilation - Chronic Obstructive Pulmonary Disease - Severity score (APACHE II >12 points) the extubation day - Body Mass Index >30 - inability to manage respiratory secretions - 1 failed spontaneous breathing trial - 1 comorbidity - 7 days under mechanical ventilation Exclusion Criteria: - <18 years - tracheotomized patients - recent facial or cervical trauma/surgery - active gastro-intestinal bleeding - lack of cooperation - patients with any failed spontaneous breathing trial because of hypercapnia development.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Respiratory Failure

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.

Device:Nasal cannulae or controlled oxygen concentration maskThe described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

High Flow Conditioned Oxygen TherapyIntervention: The Optiflow(R) device supplies oxygen in controlled concentrations and at high flow (from 10 to 70 liters/min) through special nasal cannulae. The device also humidifies the gases mixtures up to 100% relative humidity.

Standard Oxygen TherapyThe standard way of oxygen supply after extubation is either by nasal cannulae at flow between 1 and 5 liters/min or by mask with controlled oxygen concentration from 24% to 50%.

Study Status

Terminated

Start Date: March 2013

Completed Date: January 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Respiratory failure after extubation

Secondary Outcome: Survival

Study sponsors, principal investigator, and references

Principal Investigator: Rafael Fernandez, MD

Lead Sponsor: Althaia Xarxa Assistencial Universitària de Manresa

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01820507

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