Clinical trial NCT04125342: Postextubation High-flow Therapy vs Noninvasive Ventilation in Obese or at High-risk Patients
Official title: Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation in Obese or High-Risk Patients. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extubation Failure
Lead sponsor: Hospital Virgen de la Salud
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (NIV) rather than with High-flow oxygen therapy (HFOT) in obese intermediate-risk patients and in high-risk patients.


Eligibility criteria: Inclusion Criteria:

1. High-Risk Patients: Patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors:

   * \>65 years.
   * Cardiac failure as the primary indication of mechanical ventilation.
   * Moderate to severe chronic obstructive pulmonary disease.
   * APACHE II \>12 points the extubation day.
   * Body mass index \>30.
   * Inability to manage respiratory secretions.
   * Not simple weaning.
   * More than 1 comorbidity.
   * More than 7 days under mechanical ventilation.
   * Hypercapnia during the spontaneous breathing trial.
   * Airway patency problems.
2. Obese Intermediate Risk Patients: Patients under mechanical ventilation for more than 24 hours with a Body mass index \>30 and considered at intermediate risk according to the presence of less than 3 of the following risk factors:

   * \>65 years.
   * Cardiac failure as the primary indication of mechanical ventilation.
   * Moderate to severe chronic obstructive pulmonary disease.
   * APACHE II \>12 points the extubation day.
   * Inability to manage respiratory secretions.
   * Not simple weaning.
   * More than 1 comorbidity.
   * More than 7 days under mechanical ventilation.
   * Airway patency problems.

Exclusion Criteria:

* \<18 years.
* Thacheotomized patients.
* Contraindications for NIV (recent facial or cervical trauma/surgery, active gastro-intestinal bleeding, lack of cooperation).
* Unscheduled extubation.
* Do not reintubate orders.
* No informed consent.

Primary outcomes:
measure: Reintubation rate
timeFrame: 7 days
Secondary outcomes:
measure: Intensive Care Unit mortality rate
timeFrame: 3 months
measure: Hospital mortality rate
timeFrame: 3 months
measure: Intensive Care Unit length of stay
timeFrame: 3 months
measure: Hospital length of stay
timeFrame: 6 months
measure: Respiratory infection rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
state: Castilla La Mancha
city: Madrid
country: Spain
facility: La princesa University Hospital
Study officials:
affiliation: SESCAM
name: Gonzalo Hernandez
role: STUDY_CHAIR
References:
citation: Hernandez G, Paredes I, Moran F, Buj M, Colinas L, Rodriguez ML, Velasco A, Rodriguez P, Perez-Pedrero MJ, Suarez-Sipmann F, Canabal A, Cuena R, Blanch L, Roca O. Effect of postextubation noninvasive ventilation with active humidification vs high-flow nasal cannula on reintubation in patients at very high risk for extubation failure: a randomized trial. Intensive Care Med. 2022 Dec;48(12):1751-1759. doi: 10.1007/s00134-022-06919-3. Epub 2022 Nov 18.