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Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Necessity endotracheal suctioning | Experimental | Endotracheal suctioning depends on clinical manifestations |
|
| Routine endotracheal suctioning | Other | Endotracheal suctioning every two hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Necessity endotracheal suctioning | Procedure | Endotracheal suctioning depends on clinical manifestations |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Ventilation Length as Days. | Number of days under mechanical ventilation during ICU hospitalization length | Every day while patient really is intubated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria L Lema, MD | Hospital Pablo Tobon Uribe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pablo Tobon Uribe | MedellÃn | Antioquia | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30104806 | Derived | Lema-Zuluaga GL, Fernandez-Laverde M, Correa-Varela AM, Zuleta-Tobon JJ. As-needed endotracheal suctioning protocol vs a routine endotracheal suctioning in Pediatric Intensive Care Unit: A randomized controlled trial. Colomb Med (Cali). 2018 Jun 30;49(2):148-153. doi: 10.25100/cm.v49i2.2273. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Necessity Endotracheal Suctioning | Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations |
| FG001 | Routine Endotracheal Suctioning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Routine endotracheal suctioning | Procedure | Endotracheal suctioning every two hours |
|
Endotracheal suctioning every two hours
Routine endotracheal suctioning: Endotracheal suctioning every two hours
| COMPLETED |
|
| NOT COMPLETED |
|
| ID | Title | Description |
|---|---|---|
| BG000 | Necessity Endotracheal Suctioning | Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations |
| BG001 | Routine Endotracheal Suctioning | Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| suctioning number |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | months | Participants |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Weight | Median | Inter-Quartile Range | Kgs | Participants |
| ||||||||||||||
| PRISM | The PRISM score predicts the risk of mortality in critical children. It evaluates the degree of severity of the illness. Ranges are established between 0-100. As highest the number as highest the probability of dead. | Median | Inter-Quartile Range | units on a scale | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | event | 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 . | suctioning | suctioning |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Mechanical Ventilation Length as Days. | Number of days under mechanical ventilation during ICU hospitalization length | Posted | Median | Inter-Quartile Range | Days | Every day while patient really is intubated. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Necessity Endotracheal Suctioning | Endotracheal suctioning depends on clinical manifestations Necessity endotracheal suctioning: Endotracheal suctioning depends on clinical manifestations | 9 | 47 | 0 | 47 | 0 | 45 |
| EG001 | Routine Endotracheal Suctioning | Endotracheal suctioning every two hours Routine endotracheal suctioning: Endotracheal suctioning every two hours | 12 | 45 | 1 | 45 | 0 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VAP | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Ventilator Associated Pneumonia |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Jorge Donado Research Unit Chief | Pablo Tobon Uribe Hospital | +574459753 | jdonado@hptu.org.co |
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D001145 | Arrhythmias, Cardiac |
| D006323 | Heart Arrest |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
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| Male |
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|