Complication
Conditions
Keywords
airway extubation, positive-pressure respiration, suction, ventilator weaning
Brief summary
Laboratory studies suggest extubation with positive pressure because it reduces the volume of secretions filtered into the distal airway. The aim of this non inferiority study is to evaluate the safety of the extubation technique under positive pressure with respect to the traditional technique (with suction and without positive pressure in the airways).
Detailed description
The extubation procedure consists of the removal of the endotracheal tube when it is no longer required. The literature reports two methods of extubation: the named traditional method (with suction and without positive pressure in the airways) and the positive pressure method. Laboratory studies suggest extubation at positive pressure because it reduces the volume of secretions filtered into the distal airway. Prior to apply it into clinical practice the investigators of this study consider is a priority to guarantee the safety of the positive pressure extubation method in terms of presence of complications. The aim of this non-inferiority study is to compare the incidence of complications between both extubation techniques in adult patients with invasive mechanical ventilation. The hypothesis of this study is that applying positive pressure during cuff deflation and extubation is not inferior to the traditional method in the incidence of complications.
Interventions
Positive pressure ventilation without endotracheal aspiration/suction during extubation procedure.
Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.
Sponsors
Study design
Masking description
The pre and post extubation parameters are recorded by an outcome assessor who do not know the assigned extubation method. The assigned extubation method is coded to minimize potential bias during data analysis.
Intervention model description
Non-inferiority trial
Eligibility
Inclusion criteria
* Invasive Mechanical Ventilation with endotracheal tube. * 18 years and older. * Successful 30 minutes spontaneous breathing trial (SBT). * Extubation Criteria. * Informed consent.
Exclusion criteria
* Previous airway surgery or injury. * Non-Invasive Ventilation as weaning method.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence/A presence/absence of complications after extubation | 60 minutes | Clinical Evidence of at least one of the next complications: persistent cough, airway obstruction, post-obstructive pulmonary edema, bronchospasm, desaturation, vomiting, tachycardia, arterial hypertension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumonia | 72 hours | Presence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography |
| Reintubation | 72 hours | Intubation requirement after extubation |
Countries
Argentina