N/A N=77 Randomized Treatment

Non-invasive Ventilation vs Oxygen Therapy After Extubation Failure

Respiratory Failure

Bottom Line

View on ClinicalTrials.gov: NCT03832387 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Rate of Intubation — 10; 23 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Non-invasive mechanical ventilation (Device); Continuous positive airway pressure (Device); Venturi mask (Device); Reservoir mask (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Intubation	10; 23	—
SECONDARY Rate of Tracheotomy	6; 10	—
SECONDARY Intensive Care Unit Length of Stay	18; 26	—
SECONDARY Hospital Length of Stay	41; 44	—
SECONDARY Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy	37; 10	—
SECONDARY Duration of Global Mechanical Ventilation	14; 14	—
SECONDARY Rate of Intensive Care Unit Mortality	6; 6	—
SECONDARY Rate of Hospital Mortality	14; 10	—
SECONDARY Rate of 90 Days Mortality	13; 9	—
SECONDARY Rate of Ventilator Associated Pneumonia	3; 8	—
SECONDARY Rate of Urinary Tract Infection	6; 7	—
SECONDARY Rate of Bacteremia	3; 3	—

Summary

Non-invasive mechanical ventilation (NIV) has not exhibited a reduction of reintubation after extubation failure compared to oxygen therapy. The reduction of reintubation with NIV versus oxygen therapy in patients with extubation failure was evaluated. A clinical trial was conducted that included patients who underwent mechanical ventilation and developed acute respiratory failure after extubation. After extubation failure, thirty-three were assigned to NIV and thirty-two were assigned to oxygen therapy.

Eligibility Criteria

Inclusion Criteria

Medical and surgical ICU patients with 18 years of age or older
First episode of mechanical ventilation for more than 24 hours

Exclusion Criteria

Structural neurological disorder
Acute toxic-metabolic neurological encephalopathy with neurological deficit [estimated by a Glasgow Coma Score (GCS) <14 points] at the time of weaning
Neuromuscular disease
Chronic obstructive pulmonary disease (COPD) receiving NIV
Limitation of life support therapy during their admission
Tracheostomized patients
Spinal cord injuries
Scheduled surgical procedure during the 48 hours following extubation
Intensive care unit readmission
Transfer to another centre
Contraindication to non-invasive mechanical ventilation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03832387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.