NCT04125342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

October 3, 2019

Last Update Submit

March 16, 2022

Conditions

Extubation Failure

Outcome Measures

Primary Outcomes (1)

  • Reintubation rate

    7 days

Secondary Outcomes (5)

  • Intensive Care Unit mortality rate

    3 months

  • Hospital mortality rate

    3 months

  • Intensive Care Unit length of stay

    3 months

  • Hospital length of stay

    6 months

  • Respiratory infection rate

    6 months

Study Arms (4)

Conditioned NIV in High Risk Patients

EXPERIMENTAL
Device: Preventive Conditioned NIV Therapy after planned extubation

HFOT in High Risk Patients

ACTIVE COMPARATOR
Device: Preventive HFOT after planned extubation

Conditioned NIV in Obese Intermediate Risk Patients

EXPERIMENTAL
Device: Preventive Conditioned NIV Therapy after planned extubation

HFOT in Obese Intermediate Risk Patient

ACTIVE COMPARATOR
Device: Preventive HFOT after planned extubation

Interventions

Preventive Conditioned NIV Therapy after planned extubationDEVICE

Conditioned NIV during 48 hours following extubation.

Conditioned NIV in High Risk PatientsConditioned NIV in Obese Intermediate Risk Patients
Preventive HFOT after planned extubationDEVICE

HFOT set according to patients tolerance during 48 hours following extubation

HFOT in High Risk PatientsHFOT in Obese Intermediate Risk Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • +7 more criteria

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Virgen de la Salud

Toledo, Castille-La Mancha, 45007, Spain

Location

La princesa University Hospital

Madrid, 28006, Spain

Location

Related Publications (2)

  • Hernandez G, Dianti J, Paredes I, Moran F, Marquez M, Calle A, Colinas L, Alonso G, Carneiro P, Morales G, Suarez-Sipmann F, Canabal A, Goligher E, Roca O. Humidified Noninvasive Ventilation versus High-Flow Therapy to Prevent Reintubation in Patients with Obesity: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2025 Feb;211(2):222-229. doi: 10.1164/rccm.202403-0523OC.

    PMID: 39514845DERIVED

  • 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.

    PMID: 36400984DERIVED

Study Officials

  • Gonzalo Hernandez

    SESCAM

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 14, 2019

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)