Respiratory Failure Clinical Trial
Official title:
Non-Invasive Mechanical Ventilation Versus Oxygen Therapy in Patients With Acute Respiratory Failure After Extubation in a Intensive Care Unit
NCT number | NCT03832387 |
Other study ID # | HGCS03 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 29, 2009 |
Est. completion date | September 4, 2016 |
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.
Status | Completed |
Enrollment | 77 |
Est. completion date | September 4, 2016 |
Est. primary completion date | June 4, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitari Castello | Castellón De La Plana | Castello |
Lead Sponsor | Collaborator |
---|---|
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Intubation | Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy | from randomization to 1 week | |
Secondary | Rate of Tracheotomy | Need for tracheotomy after reintubation, because of prolongation of mechanical ventilation | from randomization to 3 weeks | |
Secondary | Intensive Care Unit Length of Stay | Duration of stay at intensive care unit | From intensive care unit admission to 2 months | |
Secondary | Hospital Length of Stay | Duration of stay at hospital | From hospital admission to 3 months | |
Secondary | Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy | Duration of non-invasive mechanical ventilation or oxygen therapy after randomization until success or failure. | From randomization to one week | |
Secondary | Duration of Global Mechanical Ventilation | Duration of mechanical ventilation until unsupported ventilation | From start of mechanical ventilation to one month | |
Secondary | Rate of Intensive Care Unit Mortality | Mortality during intensive care unit stay | From intensive care unit admission to 2 months | |
Secondary | Rate of Hospital Mortality | Mortality during hospital stay | From hospital admission to 3 months | |
Secondary | Rate of 90 Days Mortality | Mortality at 90 days after randomization | 90 days after randomization | |
Secondary | Rate of Ventilator Associated Pneumonia | Percentage of participants with lung infection during intensive care unit stay | From start of mechanical ventilation to 2 months | |
Secondary | Rate of Urinary Tract Infection | Percentage of participants with urinary tract infection during intensive care unit stay | From intensive care unit admission to 2 months | |
Secondary | Rate of Bacteremia | Percentage of participants with blood infection during intensive care unit stay | From intensive care unit admission to 2 months |
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