High Flow Nasal Cannula in Immediately Post Extubation

NCT03495947 | Completed

• 1 other identifier: 3027
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Extubation; Oxygen Inhalation Therapy

Keywords

High Flow Nasal Cannula (HFNC).; Mechanical ventilation; Extubation failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time to failure of extubation

  In the first 48 hours

• Reasons for extubation failure

  In the first 48 hours

• Type of ventilatory support post-failure of extubation

  In the first 48 hours

• Average time of use the HFNC

  Through study completion, an average of 1 year

• Length of stay in the Intensive care unit

  Through study completion, an average of 1 year

Interventions

high flow nasal cannula BEHAVIORAL

24 hours of continuous use in the immediate post-extubation period.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Related Publications (1)

• 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.

  PMID: 27706464 BACKGROUND

Study Officials

• Paulina E Ezcurra, Lic

  PRINCIPAL INVESTIGATOR

• Maria S Venuti, Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 12, 2018
• Study Start: December 1, 2016
• Primary Completion: January 3, 2019
• Study Completion: January 3, 2019
• Last Updated: March 4, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)