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

Primary Purpose

Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Optiflow (Fisher&Paykel)
Nasal cannulae or controlled oxygen concentration mask
Sponsored by
Althaia Xarxa Assistencial Universitària de Manresa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Post-extubation respiratory failure, Endotracheal intubation, Mechanical ventilation

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ICU. Fundacio Althaia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Flow Conditioned Oxygen Therapy

Standard Oxygen Therapy

Arm Description

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.

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%.

Outcomes

Primary Outcome Measures

Respiratory failure after extubation
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200), hypercapnia (PaCO2 > 50), respiratory acidosis (arterial pH < 7.30), severe tachypnea (>40x')

Secondary Outcome Measures

Survival

Full Information

First Posted
March 26, 2013
Last Updated
January 29, 2015
Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
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1. Study Identification

Unique Protocol Identification Number
NCT01820507
Brief Title
Extubation Failure Prevention in High Risk Patients by High-flow Conditioned Oxygen Therapy vs. Standard Oxygen Therapy
Official Title
Prevention of Post-extubation Respiratory Failure in High Risk Patients by High-flow Conditioned Oxygen Therapy Versus Standard Oxygen Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment, interim analysis
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Althaia Xarxa Assistencial Universitària de Manresa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Post-extubation respiratory failure, Endotracheal intubation, Mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Conditioned Oxygen Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Oxygen Therapy
Arm Type
Active Comparator
Arm Description
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%.
Intervention Type
Device
Intervention Name(s)
Optiflow (Fisher&Paykel)
Other Intervention Name(s)
High Flow Conditioned Oxygen Therapy
Intervention Description
The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.
Intervention Type
Device
Intervention Name(s)
Nasal cannulae or controlled oxygen concentration mask
Other Intervention Name(s)
Standard Oxygen Therapy
Intervention Description
The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.
Primary Outcome Measure Information:
Title
Respiratory failure after extubation
Description
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200), hypercapnia (PaCO2 > 50), respiratory acidosis (arterial pH < 7.30), severe tachypnea (>40x')
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Survival
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Fernandez, MD
Organizational Affiliation
Fundacio Althaia
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICU. Fundacio Althaia
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08242
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28466461
Citation
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.
Results Reference
derived

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

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