Airway ExtubationHFNCNCT03495947
High Flow Nasal Cannula in Immediately Post Extubation
An observational study of Airway Extubation and Oxygen Inhalation Therapy, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The aim of the study is to determine the incidence of failure of extubation in high-risk patients using High Flow Nasal Cannula (HFNC) to prevent such failure in the Intensive Care Unit. A prospective cohort study was performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Extubation, Oxygen Inhalation Therapy
- What is being tested?
- high flow nasal cannula
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 165 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Dec 2016to 3 Jan 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients receiving invasive mechanical ventilation ≥48 hours and ready for scheduled extubation according to tolerance of spontaneous breathing trial.
Who may be able to join
- All adult patients receiving invasive mechanical ventilation ≥48 hours and ready for scheduled extubation according to tolerance of spontaneous breathing trial, with at least one of the following criteria for high-risk for extubation failure:
- Age greater than 65 years.
- Hypoxemic acute respiratory failure as a cause of invasive mechanical ventilation.
- >1 spontaneous ventilation test failed consecutive.
- History of chronic heart failure.
- History of chronic obstructive pulmonary disease or PaCO2 >45 mmHg.
- Body mass index >30 kg/m2.
- Post-operative solid organ transplantation.
Who cannot join
- Need for orotracheal intubation and invasive mechanical ventilation (IOT / AVMI) according to the decision of the attending physician.
- Deterioration of the state of consciousness determined by Kelly Matthay's Scale >3.
- Hemodynamic instability: systolic blood pressure (TAS) <90 mmHg or TAM <65 mmHg despite receiving fluids and/ or vasopressors.
- Neuromuscular disease
- Neurocritical pathology.
- Epistaxis
Show all 11Show fewer
- Skull base fracture, or inability to fix the HFNC.
- History of obstructive sleep apnea-hypopnea syndrome with indication and use of nocturnal continuous positive pressure.
- Participation in another research protocol of HFNC.
- Elimination criteria
- . Directives before or after the onset of a disease that limits the therapeutic effort and indicates not to intubate or perform cardiopulmonary resuscitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Results of the Application of High Flow Nasal Cannula to Prevent the Failure of Extubation
The aim of the study is to determine the incidence of failure of extubation in high-risk patients using High Flow Nasal Cannula (HFNC) to prevent such failure in the Intensive Care Unit. A prospective cohort study was performed. To all adult patients receiving invasive mechanical ventilation ≥ 48 hours and ready for scheduled extubation according to tolerance of spontaneous breathing trial, with at least one of the criteria for high-risk for extubation failure (age greater than 65 years, hypoxemic acute respiratory failure as a cause of invasive mechanical ventilation, > 1 spontaneous ventilation test failed consecutive, history of chronic heart failure, history of chronic obstructive pulmonary disease or PaCO2> 45 mmHg, body mass index >30 kg/m2, post-operative solid organ transplantation), HFNC is applied for 24 hours. Demographic variables and clinical and gasometric parameters at the end of the spontaneous breathing trial, at 60 minutes, at 6 and 24 hours after the start of HFNC are recorded.
Read the detailed description
At the end of the successful spontaneous breathing trial, clinical and gasometric parameters will be recorded and extubation will be performed. HFNC is placed with a flow of 50 l / m (only the flow is reduced before intolerance, at 5 l / min but only up to 40 l / min). Inspiratory oxygen fraction (FiO2) initially at 1 and progressively decreases until pulse oximeter saturation (SpO2) ≥ 92% is achieved. Said configuration is maintained for 60 minutes. After this time, arterial blood samples are taken and clinical and gasometric parameters are recorded in the follow-up chart. Based on them, behavior to be followed is defined. If "Fault criteria" are presented, a higher ventilatory support will be initiated. If not, continue with HFNC for the next 23 hours without exception. In this period the initial flow is maintained (40 to 50 l / min) and the FiO2 is programmed according to the SpO2 objective (≥ 92%). At 6 o'clock a new clinical and gasometric evaluation and data loading is carried out. 24 hours after the start of HFNC, a blood gas sample is taken and clinical and gasometric parameters are recorded. Treatment with HFNC is only suspended if the "Failure criteria" or the "Interruption criteria" are met. In the presence of the "Failure Criteria" and prior to delivering a greater ventilatory support, the clinical and gasometric parameters are recorded in the spreadsheet.
The data of categorical variables will be presented as frequency and percentage, while in quantitative variables, after testing normality by Shapiro-Wilks test, they will be presented as mean and standard deviation or median and interquartile range depending on their distribution. For comparisons between groups, chi-square or Fisher tests will be used, depending on the frequency expected in discrete and categorical variables, and in the continuous T or Mann-Whitney tests, depending on the type of distribution and variance. To determine the factors of risk of failure to extubation, a logistic regression study will be carried out with a system of selection of variables by forward steps. The odds ratio and its 95% confidence intervals will be calculated. Variables that are significant in the univariate study (p value <0.2) will be included in the multiple logistic regression study.
- Conditions
- Airway Extubation, Oxygen Inhalation Therapy
- Being tested
- high flow nasal cannula
- Keywords
- High Flow Nasal Cannula (HFNC)., Mechanical ventilation, Extubation failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaBehavioural
24 hours of continuous use in the immediate post-extubation period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
the need to discontinue treatment with HFNC to progress to invasive or non-invasive ventilatory support within 48 hours of extubation.
Measured: In the first 48 hours
Secondary outcomes (6)
Time to failure of extubation
the date and time of extubation and start of HFNC will be recorded as well as the date and time of discontinuation of HFNC to progress to another type of ventilatory support within 48 hours following extubation.
Measured: In the first 48 hours
Reasons for extubation failure
the cause of extubation failure
Measured: In the first 48 hours
Type of ventilatory support post-failure of extubation
the type of ventilatory support post-failure will be recorded. Non-invasive mechanical ventilatory. Intubation orotracheal and invasive mechanical ventilatory.
Measured: In the first 48 hours
Average time of use the HFNC
the total hours of use of HFNC will be recorded
Measured: Through study completion, an average of 1 year
Length of stay in the Intensive care unit
the total number of days of stay in the Intensive care unit will be recorded.
Measured: Through study completion, an average of 1 year
Incidence of mortality in the Intensive care unit
the relationship between the total number of patients requiring HFNC and those who died after being included in the study will be recorded.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Dec 2016
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
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 Airway ExtubationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulina E Ezcurra, Lic, Principal investigatorMaria S Venuti, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495947
- Sponsor's protocol ID
- 3027
- Acronym
- HFNC
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2018
- Last updated
- 4 Mar 2019
- Results posted
- No
- Individual data sharing
- No
Publications
Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
PubMed 27706464
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Results of the Application of High Flow Nasal Cannula to Prevent the Failure of Extubation
- ClinicalTrials.gov ID
- NCT03495947
- Acronym / sponsor ID
- HFNC / 3027
- Conditions
- Airway Extubation, Oxygen Inhalation Therapy
- Keywords
- High Flow Nasal Cannula (HFNC)., Mechanical ventilation, Extubation failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 12 Apr 2018 (actual)
- 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.
The aim of the study is to determine the incidence of failure of extubation in high-risk patients using High Flow Nasal Cannula (HFNC) to prevent such failure in the Intensive Care Unit. A prospective cohort study was performed. To all adult patients receiving invasive mechanical ventilation ≥ 48 hours and ready for scheduled extubation according to tolerance of spontaneous breathing trial, with at least one of the criteria for high-risk for extubation failure (age greater than 65 years, hypoxemic acute respiratory failure as a cause of invasive mechanical ventilation, > 1 spontaneous ventilation test failed consecutive, history of chronic heart failure, history of chronic obstructive pulmonary disease or PaCO2> 45 mmHg, body mass index >30 kg/m2, post-operative solid organ transplantation), HFNC is applied for 24 hours. Demographic variables and clinical and gasometric parameters at the end of the spontaneous breathing trial, at 60 minutes, at 6 and 24 hours after the start of HFNC are recorded.
Detailed description
At the end of the successful spontaneous breathing trial, clinical and gasometric parameters will be recorded and extubation will be performed. HFNC is placed with a flow of 50 l / m (only the flow is reduced before intolerance, at 5 l / min but only up to 40 l / min). Inspiratory oxygen fraction (FiO2) initially at 1 and progressively decreases until pulse oximeter saturation (SpO2) ≥ 92% is achieved. Said configuration is maintained for 60 minutes. After this time, arterial blood samples are taken and clinical and gasometric parameters are recorded in the follow-up chart. Based on them, behavior to be followed is defined. If "Fault criteria" are presented, a higher ventilatory support will be initiated. If not, continue with HFNC for the next 23 hours without exception. In this period the initial flow is maintained (40 to 50 l / min) and the FiO2 is programmed according to the SpO2 objective (≥ 92%). At 6 o'clock a new clinical and gasometric evaluation and data loading is carried out. 24 hours after the start of HFNC, a blood gas sample is taken and clinical and gasometric parameters are recorded. Treatment with HFNC is only suspended if the "Failure criteria" or the "Interruption criteria" are met. In the presence of the "Failure Criteria" and prior to delivering a greater ventilatory support, the clinical and gasometric parameters are recorded in the spreadsheet.
The data of categorical variables will be presented as frequency and percentage, while in quantitative variables, after testing normality by Shapiro-Wilks test, they will be presented as mean and standard deviation or median and interquartile range depending on their distribution. For comparisons between groups, chi-square or Fisher tests will be used, depending on the frequency expected in discrete and categorical variables, and in the continuous T or Mann-Whitney tests, depending on the type of distribution and variance. To determine the factors of risk of failure to extubation, a logistic regression study will be carried out with a system of selection of variables by forward steps. The odds ratio and its 95% confidence intervals will be calculated. Variables that are significant in the univariate study (p value <0.2) will be included in the multiple logistic regression study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients receiving invasive mechanical ventilation ≥48 hours and ready for scheduled extubation according to tolerance of spontaneous breathing trial.
Key inclusion criteria (8 listed)
- All adult patients receiving invasive mechanical ventilation ≥48 hours and ready for scheduled extubation according to tolerance of spontaneous breathing trial, with at least one of the following criteria for high-risk for extubation failure:
- Age greater than 65 years.
- Hypoxemic acute respiratory failure as a cause of invasive mechanical ventilation.
- >1 spontaneous ventilation test failed consecutive.
- History of chronic heart failure.
Key exclusion criteria (11 listed)
- Need for orotracheal intubation and invasive mechanical ventilation (IOT / AVMI) according to the decision of the attending physician.
- Deterioration of the state of consciousness determined by Kelly Matthay's Scale >3.
- Hemodynamic instability: systolic blood pressure (TAS) <90 mmHg or TAM <65 mmHg despite receiving fluids and/ or vasopressors.
- Neuromuscular disease
- Neurocritical pathology.
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 |
|---|---|---|
| high flow nasal cannula24 hours of continuous use in the immediate post-extubation period. | Behavioural | – |
Primary outcome
Extubation failure
Time frame: In the first 48 hours
the need to discontinue treatment with HFNC to progress to invasive or non-invasive ventilatory support within 48 hours of extubation.
6 secondary outcomes
Time to failure of extubation
Time frame: In the first 48 hours
Reasons for extubation failure
Time frame: In the first 48 hours
Type of ventilatory support post-failure of extubation
Time frame: In the first 48 hours
Average time of use the HFNC
Time frame: Through study completion, an average of 1 year
Length of stay in the Intensive care unit
Time frame: Through study completion, an average of 1 year
Incidence of mortality in the Intensive care unit
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Background: PubMed 27706464Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
- Individual participant dataSharing planned: No
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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.
Paulina E Ezcurra, Lic principal investigator
Maria S Venuti, Dr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Extubation and Oxygen Inhalation Therapy, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 4 Mar 2019. 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 Argentina. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Extubation failure (time frame: In the first 48 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 NCT03495947, 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 4 Mar 2019.