High Flow Nasal Cannula in Immediately Post Extubation (HFNC)
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|ClinicalTrials.gov Identifier: NCT03495947|
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : March 4, 2019
|Condition or disease||Intervention/treatment|
|Airway Extubation Oxygen Inhalation Therapy||Behavioral: high flow nasal cannula|
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 Type :||Observational|
|Actual Enrollment :||165 participants|
|Official Title:||Evaluation of Results of the Application of High Flow Nasal Cannula to Prevent the Failure of Extubation|
|Actual Study Start Date :||December 1, 2016|
|Actual Primary Completion Date :||January 3, 2019|
|Actual Study Completion Date :||January 3, 2019|
- Behavioral: high flow nasal cannula
24 hours of continuous use in the immediate post-extubation period.
- 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.
- Time to failure of extubation [ Time Frame: In the first 48 hours ]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.
- Reasons for extubation failure [ Time Frame: In the first 48 hours ]the cause of extubation failure
- Type of ventilatory support post-failure of extubation [ Time Frame: In the first 48 hours ]the type of ventilatory support post-failure will be recorded. Non-invasive mechanical ventilatory. Intubation orotracheal and invasive mechanical ventilatory.
- Average time of use the HFNC [ Time Frame: Through study completion, an average of 1 year ]the total hours of use of HFNC will be recorded
- Length of stay in the Intensive care unit [ Time Frame: Through study completion, an average of 1 year ]the total number of days of stay in the Intensive care unit will be recorded.
- Incidence of mortality in the Intensive care unit [ Time Frame: Through study completion, an average of 1 year ]the relationship between the total number of patients requiring HFNC and those who died after being included in the study will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495947
|Hospital Italiano de Buenos Aires|
|Buenos Aires, Argentina, C1181ACH|
|Principal Investigator:||Paulina E Ezcurra, Lic|
|Principal Investigator:||Maria S Venuti, Dr|