Postextubation High-flow Therapy vs Noninvasive Ventilation in Obese or at High-risk Patients (HINFOR)

Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation in Obese or High-Risk Patients. A Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Extubation Failure
• Intervention / Treatment: Device: Preventive Conditioned NIV Therapy after planned extubation; Device: Preventive HFOT after planned extubation

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • La Princesa University Hospital
  • Castilla La Mancha
    • Toledo, Castilla La Mancha, Spain, 45007
      • Hospital Virgen de la Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conditioned NIV in High Risk Patients	Device: Preventive Conditioned NIV Therapy after planned extubation; Conditioned NIV during 48 hours following extubation.
Active Comparator: HFOT in High Risk Patients	Device: Preventive HFOT after planned extubation; HFOT set according to patients tolerance during 48 hours following extubation
Experimental: Conditioned NIV in Obese Intermediate Risk Patients	Device: Preventive Conditioned NIV Therapy after planned extubation; Conditioned NIV during 48 hours following extubation.
Active Comparator: HFOT in Obese Intermediate Risk Patient	Device: Preventive HFOT after planned extubation; HFOT set according to patients tolerance during 48 hours following extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reintubation rate	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital length of stay	6 months
Intensive Care Unit mortality rate	3 months
Hospital mortality rate	3 months
Intensive Care Unit length of stay	3 months
Respiratory infection rate	6 months

Collaborators and Investigators

• Sponsor: Hospital Virgen de la Salud
• Investigators: Study Chair: Gonzalo Hernandez, SESCAM

Publications and helpful links

General Publications

• 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. Erratum In: Intensive Care Med. 2023 Jan 27;:

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 25/9/2019 nº17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No