NCT01820507

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

March 26, 2013

Last Update Submit

January 29, 2015

Conditions

Respiratory Failure

Keywords

Post-extubation respiratory failureEndotracheal intubationMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Respiratory failure after extubation

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

    72 hours

Secondary Outcomes (1)

  • Survival

    90 days

Study Arms (2)

High Flow Conditioned Oxygen Therapy

EXPERIMENTAL

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.

Device: Optiflow (Fisher&Paykel)

Standard Oxygen Therapy

ACTIVE COMPARATOR

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%.

Device: Nasal cannulae or controlled oxygen concentration mask

Interventions

Optiflow (Fisher&Paykel)DEVICE

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

Also known as: High Flow Conditioned Oxygen Therapy
High Flow Conditioned Oxygen Therapy
Nasal cannulae or controlled oxygen concentration maskDEVICE

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

Also known as: Standard Oxygen Therapy
Standard Oxygen Therapy

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • failed spontaneous breathing trial
  • comorbidity
  • days under mechanical ventilation

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU. Fundacio Althaia

Manresa, Barcelona, 08242, Spain

Location

Related Publications (1)

  • 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.

    PMID: 28466461DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Cannula

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Study Officials

  • Rafael Fernandez, MD

    Fundacio Althaia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Intensive Care Department

Study Record Dates

First Submitted

March 26, 2013

First Posted

March 28, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

ES(1)