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

NCT ID: NCT01820507

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Failure

Keywords

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Post-extubation respiratory failure Endotracheal intubation Mechanical ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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High Flow Conditioned Oxygen Therapy

Intervention: 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.

Group Type EXPERIMENTAL

Optiflow (Fisher&Paykel)

Intervention Type DEVICE

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

Standard Oxygen Therapy

The 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%.

Group Type ACTIVE_COMPARATOR

Nasal cannulae or controlled oxygen concentration mask

Intervention Type DEVICE

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

Interventions

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Optiflow (Fisher&Paykel)

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

Intervention Type DEVICE

Nasal cannulae or controlled oxygen concentration mask

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

Intervention Type DEVICE

Other Intervention Names

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High Flow Conditioned Oxygen Therapy Standard Oxygen Therapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Althaia Xarxa Assistencial Universitària de Manresa

OTHER

Sponsor Role lead

Responsible Party

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Rafael Fernandez

Head of Intensive Care Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacio Althaia

Locations

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ICU. Fundacio Althaia

Manresa, Barcelona, Spain

Site Status

Countries

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Spain

References

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Fernandez R, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Masclans JR, Lesmes A, Panadero L, Hernandez G. High-flow nasal cannula to prevent postextubation respiratory failure in high-risk non-hypercapnic patients: a randomized multicenter trial. Ann Intensive Care. 2017 Dec;7(1):47. doi: 10.1186/s13613-017-0270-9. Epub 2017 May 2.

Reference Type DERIVED
PMID: 28466461 (View on PubMed)

Other Identifiers

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CEIC 12/85

Identifier Type: -

Identifier Source: org_study_id