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

Not Applicable

Completed

• Conditions: Extubation Failure
• Interventions: Device: Preventive HFOT after planned extubation; Device: Preventive Conditioned NIV Therapy after planned extubation

• Registration Number: NCT04125342
• Lead Sponsor: Hospital Virgen de la Salud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Study Start: 2020-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFOT in Obese Intermediate Risk Patient	Preventive HFOT after planned extubation	-
HFOT in High Risk Patients	Preventive HFOT after planned extubation	-
Conditioned NIV in Obese Intermediate Risk Patients	Preventive Conditioned NIV Therapy after planned extubation	-
Conditioned NIV in High Risk Patients	Preventive Conditioned NIV Therapy after planned extubation	-

Primary Outcome Measures

Name	Time	Method
Reintubation rate	7 days

Secondary Outcome Measures

Name	Time	Method
Respiratory infection rate	6 months
Intensive Care Unit length of stay	3 months
Hospital mortality rate	3 months
Hospital length of stay	6 months
Intensive Care Unit mortality rate	3 months

Trial Locations

Locations (2)

La princesa University Hospital; 🇪🇸 Madrid, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Castilla La Mancha, Spain