Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

High Flow Nasal Cannula in Immediately Post Extubation (HFNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495947
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Italiano de Buenos Aires

Brief 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. 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.

Condition or disease Intervention/treatment
Airway Extubation Oxygen Inhalation Therapy Behavioral: high flow nasal cannula

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Behavioral: high flow nasal cannula
    24 hours of continuous use in the immediate post-extubation period.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Reasons for extubation failure [ Time Frame: In the first 48 hours ]
    the cause of extubation failure

  3. 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.

  4. 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

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients receiving invasive mechanical ventilation ≥48 hours and ready for scheduled extubation according to tolerance of spontaneous breathing trial.
Criteria

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.


Information from the National Library of Medicine

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


Locations
Layout table for location information
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
Layout table for investigator information
Principal Investigator: Paulina E Ezcurra, Lic
Principal Investigator: Maria S Venuti, Dr
Publications:
Layout table for additonal information
Responsible Party: Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT03495947    
Other Study ID Numbers: 3027
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospital Italiano de Buenos Aires:
High Flow Nasal Cannula (HFNC).
Mechanical ventilation
Extubation failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes