oninvasive ventilation in weaning patients with hypoxemic acute respiratory failure (h-ARF): a multicentre randomized controlled study.

Not Applicable

Completed

• Conditions: Respiratory - Other respiratory disorders / diseases; Weaning in Hypoxemic Acute Respiratory Failure

• Registration Number: ACTRN12613001114730
• Lead Sponsor: avalesi Paolo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Invasive mechanical ventilation duration > 48 hours; PaO2/FiO2 ranging between 200 and 300 with a positive end-expiratory pressure PEEP > 8 and < = 12 cmH2O and a FiO2 <= 0.6; Pressure Support Ventilation (PSV) with a total applied pressure (i.e. PEEP + inspiratory support) <= 25 cmH2O; PaCO2 <= 50 mmHg; pH >= 7.35; Respiratory rate (RR) <= 30/min; Core body temperature <= 38.5 (degrees celsius); Glasgow Coma Scale (GCS) >= 10; Presence of clearly audible cough during suctioning; Tracheal suctioning<= 2/hr

Exclusion Criteria

Severe hemodynamic instability as assessed: a) systolic arterial pressure < 90 mmHg, despite adequate filling, b) need for continuous infusion of epinephrine, norepinephrine or vasopressine, c) need for dopamine or dobutamine > 5microg/Kg/min
Life-threatening arrhythmias or ECG signs of ischemia; Severe sepsis or septic shock;
ARF secondary to congestive heart failure, neurological disorders, status asmaticus, chronic obstructive pulmonary disease; Tracheotomy; Copious secretions or uncontrolled vomiting; Spinal cord injury or neuro-muscular disorder; Presence of 2 or more criteria of organ failure; Body mass index >= 30; Obstructive sleep apnea syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aim of the study is to investigate whether in patients with hypoxemic ARF early extubation followed by immediate application of NIV (interventional group) reduces the overall number of days spent in ICU.[Clinicians will monitor daily the number of days spent in intensive care unit (ICU).]

Secondary Outcome Measures

Name	Time	Method
Duration (days) of continuous intravenous sedation (monitored by clinicians).[Daily monitored during intensive care unit (ICU) stay after the inclusion in the weaning protocol.];Side effects / complications of invasive mechanical ventilation: infection, sepsis and ventilator associated pneumonia (VAP), monitored by clinicians.[Daily monitored during ICU stay after the inclusion in the weaning protocol.];ICU mortality, monitored by clinicians.[Daily monitored during ICU stay after the inclusion in the weaning protocol.];Number of tracheotomy, monitored by clinicians.[Daily monitored during ICU stay after the inclusion in the weaning protocol.];Hospital mortality, monitored by clinicians.[Daily monitored after discharge from the ICU.]