Airway Extubation Clinical Trial
— HFNCOfficial title:
Evaluation of Results of the Application of High Flow Nasal Cannula to Prevent the Failure of Extubation
NCT number | NCT03495947 |
Other study ID # | 3027 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2016 |
Est. completion date | January 3, 2019 |
Verified date | March 2019 |
Source | Hospital Italiano de Buenos Aires |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 165 |
Est. completion date | January 3, 2019 |
Est. primary completion date | January 3, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - 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. Exclusion criteria: - 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 - 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Italiano de Buenos Aires | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Hospital Italiano de Buenos Aires |
Argentina,
Hernández G, Vaquero C, Colinas L, Cuena R, González P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernández 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. Erratum in: JAMA. 2016 Nov 15;316(19):2047-2048. Erratum in: JAMA. 2017 Feb 28;317(8):858. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Extubation failure | the need to discontinue treatment with HFNC to progress to invasive or non-invasive ventilatory support within 48 hours of extubation. | In the first 48 hours | |
Secondary | 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. | In the first 48 hours | |
Secondary | Reasons for extubation failure | the cause of extubation failure | In the first 48 hours | |
Secondary | 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. | In the first 48 hours | |
Secondary | Average time of use the HFNC | the total hours of use of HFNC will be recorded | Through study completion, an average of 1 year | |
Secondary | Length of stay in the Intensive care unit | the total number of days of stay in the Intensive care unit will be recorded. | Through study completion, an average of 1 year | |
Secondary | 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. | Through study completion, an average of 1 year |
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