Complication of Respirator [Ventilator], Weaning Failure
Conditions
Keywords
ventilator weaning, protocol
Brief summary
Prolongation of mechanical ventilation poses serious personal and financial threats to healthcare consumers. The investigators objectives are create and implement an multidisciplinary evidenced-based ventilator-weaning protocol to assess whether a systematic approach compared with the physician's judgment only decreases time spent on the ventilator, complications of mechanical ventilation and length of stay in critical care unit.
Interventions
OTHERMultidisciplinary weaning-ventilator protocol
We implemented a multidisciplinary protocol for weaning from mechanical ventilation.This consist of a daily screening for readiness, performing a spontaneous breathing test, evaluation of signs of intolerance and decision on extubation.
Sponsors
Federal University of Uberlandia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* remain in mechanical ventilation for more than 24 hours * begin weaning from mechanical ventilation
Exclusion criteria
* admitted in the unit already in weaning from mechanical ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | length of ICU stay (days) |
| Duration of Weaning From Mechanical Ventilation | days |
| Duration of Mechanical Ventilation | days |
| Length of Intensive Care Unit Stay | days |
Countries
Brazil
Participant flow
Recruitment details
Adult patients hospitalized in the intensive care unit, remained on mechanical ventilation for more than 24 hours and subjected to weaning from mechanical ventilation.
Participants by arm
| Arm | Count |
|---|---|
| Protocol-directed Discontinuation of ventilation was based in multidisciplinary protocol. | 139 |
| Usual Care Discontinuation of ventilation was left entirely to the discretion of the physicians. | 96 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Care Usual | Lost to Follow-up | 0 | 1 |
| Care Usual | Protocol Violation | 0 | 172 |
| Protocol | Protocol Violation | 275 | 0 |
Baseline characteristics
| Characteristic | Protocol-directed | Usual Care | Total |
|---|---|---|---|
| Age Continuous | 49.9 years STANDARD_DEVIATION 20.18 | 43.5 years STANDARD_DEVIATION 17.89 | 47.28 years STANDARD_DEVIATION 19.5 |
| Region of Enrollment Brazil | 139 participants | 96 participants | 235 participants |
| Sex: Female, Male Female | 38 Participants | 33 Participants | 71 Participants |
| Sex: Female, Male Male | 101 Participants | 63 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Duration of Mechanical Ventilation
Time frame: days
Primary
Duration of Weaning From Mechanical Ventilation
Time frame: days
Population: overall
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protocol-directed | Duration of Weaning From Mechanical Ventilation | 3.6 days | Standard Deviation 5.49 |
| Usual Care | Duration of Weaning From Mechanical Ventilation | 6.8 days | Standard Deviation 9.45 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Primary
Length of Intensive Care Unit Stay
Time frame: days
Primary
Mortality
Time frame: length of ICU stay (days)
Population: Overall
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Protocol-directed | Mortality | 10 participants |
| Usual Care | Mortality | 14 participants |
p-value: 0.03binomial test