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

Extubation Failure Clinical Trial

— HINFOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125342
• Other study ID #: 25/9/2019 nº17
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• Source: Hospital Virgen de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extubation Failure

Intervention

Device:
• Preventive Conditioned NIV Therapy after planned extubation
Conditioned NIV during 48 hours following extubation.
• Preventive HFOT after planned extubation
HFOT set according to patients tolerance during 48 hours following extubation

Locations

Country	Name	City	State
Spain	La princesa University Hospital	Madrid
Spain	Hospital Virgen de la Salud	Toledo	Castilla La Mancha

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Virgen de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintubation rate		7 days
Secondary	Intensive Care Unit mortality rate		3 months
Secondary	Hospital mortality rate		3 months
Secondary	Intensive Care Unit length of stay		3 months
Secondary	Hospital length of stay		6 months
Secondary	Respiratory infection rate		6 months