Respiratory FailureNCT01820507
Extubation Failure Prevention in High Risk Patients by High-flow Conditioned Oxygen Therapy vs. Standard Oxygen Therapy
A study testing Optiflow (Fisher&Paykel) in people with Respiratory Failure, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
Trial 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)". Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Optiflow (Fisher&Paykel)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- inability to manage respiratory secretions
- 1 failed spontaneous breathing trial
- 1 comorbidity
- 7 days under mechanical ventilation
Who cannot join
- <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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Post-extubation Respiratory Failure in High Risk Patients by High-flow Conditioned Oxygen Therapy Versus Standard Oxygen Therapy
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.
- Conditions
- Respiratory Failure
- Being tested
- Optiflow (Fisher&Paykel), Nasal cannulae or controlled oxygen concentration mask
- Keywords
- Post-extubation respiratory failure, Endotracheal intubation, Mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflow (Fisher&Paykel)Device
Also called High Flow Conditioned Oxygen Therapy
The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.
Nasal cannulae or controlled oxygen concentration maskDevice
Also called Standard Oxygen Therapy
The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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%. Receives: Device: Nasal cannulae or controlled oxygen concentration mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory failure after extubation
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200), hypercapnia (PaCO2 > 50), respiratory acidosis (arterial pH < 7.30), severe tachypnea (>40x')
Measured: 72 hours
Secondary outcomes (1)
Survival
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2014
- Study completionJan 2015
Why it stopped: Slow recruitment, interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Rafael Fernandez, MD, Principal investigator, Fundacio Althaia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820507
- Sponsor's protocol ID
- CEIC 12/85
- Status last verified
- Jan 2015
- First submitted
- 26 Mar 2013
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28466461
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-extubation Respiratory Failure in High Risk Patients by High-flow Conditioned Oxygen Therapy Versus Standard Oxygen Therapy
- ClinicalTrials.gov ID
- NCT01820507
- Acronym / sponsor ID
- CEIC 12/85
- Conditions
- Respiratory Failure
- Keywords
- Post-extubation respiratory failure, Endotracheal intubation, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment, interim analysis
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Conditioned Oxygen Therapy | Experimental | Device: Optiflow (Fisher&Paykel)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. |
| Standard Oxygen Therapy | Active comparator | Device: Nasal cannulae or controlled oxygen concentration maskThe 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%. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- <18 years
- tracheotomized patients
- recent facial or cervical trauma/surgery
- active gastro-intestinal bleeding
- lack of cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optiflow (Fisher&Paykel)Also: High Flow Conditioned Oxygen TherapyThe described method of oxygen supply will be maintained continuously for the first 24 hours after extubation. | Device | High Flow Conditioned Oxygen Therapy |
| Nasal cannulae or controlled oxygen concentration maskAlso: Standard Oxygen TherapyThe described method of oxygen supply will be maintained continuously for the first 24 hours after extubation. | Device | Standard Oxygen Therapy |
Primary outcome
Respiratory failure after extubation
Time frame: 72 hours
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200), hypercapnia (PaCO2 > 50), respiratory acidosis (arterial pH < 7.30), severe tachypnea (>40x')
1 secondary outcome
Survival
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Slow recruitment, interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Derived from this study: PubMed 28466461Fernandez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Fernandez, MD principal investigator
Fundacio Althaia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow (Fisher&Paykel) in people with Respiratory Failure, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment, interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory failure after extubation (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01820507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.