Arrhythmias, Cardiac Arrest, Hypoxemia, Ventilator Associated Pneumonia
Conditions
Keywords
Unplanned extubation, Length of stay in PICU, Length of mechanical ventilation
Brief summary
Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.
Detailed description
Endotracheal aspiration is a very useful procedure. It has several adverse events every time that aspiration is practiced. This trials wants to identify which protocol (necessity versus routine) could be better to practice in pediatrics intensive care unit with less risk.
Interventions
PROCEDURENecessity endotracheal suctioning
Endotracheal suctioning depends on clinical manifestations
PROCEDURERoutine endotracheal suctioning
Endotracheal suctioning every two hours
Sponsors
Hospital Pablo Tobón Uribe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 14 Years
Healthy volunteers
No
Inclusion criteria
* Children older than 1 month until 14 years old requiring orotracheal intubation
Exclusion criteria
* High frequency ventilation mode
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Composite End Point | Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period . | All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Ventilation Length as Days. | Every day while patient really is intubated. | Number of days under mechanical ventilation during ICU hospitalization length |
Countries
Colombia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Necessity Endotracheal Suctioning Endotracheal suctioning depends on clinical manifestations
Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations | 47 |
| Necessity Endotracheal Suctioning Endotracheal suctioning depends on clinical manifestations
Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations | 606 |
| Routine Endotracheal Suctioning Endotracheal suctioning every two hours
Routine endotracheal suctioning: Endotracheal suctioning every two hours | 45 |
| Routine Endotracheal Suctioning Endotracheal suctioning every two hours
Routine endotracheal suctioning: Endotracheal suctioning every two hours | 649 |
| Total | 1,347 |
Baseline characteristics
| Characteristic | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning | Total |
|---|---|---|---|
| Age, Continuous | 34 months | 56 months | 40.5 months |
| PRISM | 23 units on a scale | 23 units on a scale | 23 units on a scale |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Male | 26 Participants | 22 Participants | 48 Participants |
| Weight | 15 Kgs | 15 Kgs | 15 Kgs |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 47 | 12 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 1 / 45 |
Outcome results
Primary
Primary Composite End Point
All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.
Time frame: Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Necessity Endotracheal Suctioning | Primary Composite End Point | 35 event |
| Routine Endotracheal Suctioning | Primary Composite End Point | 48 event |
Secondary
Mechanical Ventilation Length as Days.
Number of days under mechanical ventilation during ICU hospitalization length
Time frame: Every day while patient really is intubated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Necessity Endotracheal Suctioning | Mechanical Ventilation Length as Days. | 2.5 Days |
| Routine Endotracheal Suctioning | Mechanical Ventilation Length as Days. | 2.4 Days |