Weaning Failure
Conditions
Keywords
Mechanical ventilation, Weaning, Extubation failure
Brief summary
To evaluate if a rest period before extubation after a successful SBT trial could reduce the extubation failure rate.
Detailed description
Intubation and mechanical ventilation are related with several complications. This increased the risk of mortality of intensive care patients. So, we always look for an early extubation when patients are recovered for the trigger disease. In spite of standardized manoeuvres to decided readiness for extubation these are not quite good because it has been described a failure extubation rate of 5% and a reintubation rate of 15%. Furthermore several risk factors has been associated with a major failure rate:\>65 years old, congestive cardiac insufficiency, chronic obstructive pulmonary disease, APACHE II \>12 the extubation day, BMI \>30, ineffective cough, a lot of bronchial secretions (as the need for \>2 endotracheal suctioning in the last 8h before extubation), failure of a previous SBT,alterations of high respiratory tract or intubation for more than 7 days.Patients without any of these factors risk has an extubation failure rate of 10% while if any of these are present extubation failure increase to 30%. The most used technique as a weaning trial is named spontaneous breathing trial (SBT). Some physiological aspects suggest that breathing through an endotracheal tube could be a really effort trial. So our hypothesis is that a period of rest after SBT and before extubation could reduce the extubation failure rate.
Interventions
PROCEDUREREST
After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.
Sponsors
Althaia Xarxa Assistencial Universitària de Manresa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients ventilated for more than 12h and ready to perform a SBT
Exclusion criteria
* patients under 18 years old, * tracheostomy, * excessive bronchial secretions, * agitation, * hypercapnia during SBT and not resuscitation orders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Extubation Failure | 48 hours | Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation |
Secondary
| Measure | Time frame |
|---|---|
| ICU Mortality | up to 3 months |
Countries
Spain
Participant flow
Pre-assignment details
Slight number of patients were enrolled after reaching the planned sample due to information delay.
Participants by arm
| Arm | Count |
|---|---|
| SBT and Extubation After a SBT patients will be extubated as usual | 243 |
| SBT and Rest 60 Min Before Extubation After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation
REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation. | 227 |
| Total | 470 |
Baseline characteristics
| Characteristic | SBT and Extubation | SBT and Rest 60 Min Before Extubation | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 15 | 65 years STANDARD_DEVIATION 15 | 63.5 years STANDARD_DEVIATION 15 |
| Region of Enrollment Spain | 243 participants | 227 participants | 470 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 243 | 0 / 227 |
| serious Total, serious adverse events | 0 / 243 | 0 / 227 |
Outcome results
Primary
Number of Patients With Extubation Failure
Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBT and Extubation | Number of Patients With Extubation Failure | 58 Participants |
| SBT and Rest 60 Min Before Extubation | Number of Patients With Extubation Failure | 24 Participants |
Secondary
ICU Mortality
Time frame: up to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SBT and Extubation | ICU Mortality | 12 Participants |
| SBT and Rest 60 Min Before Extubation | ICU Mortality | 10 Participants |