An interventional study of Necessity endotracheal suctioning and Routine endotracheal suctioning in Hypoxemia, Arrhythmias and Cardiac Arrest, sponsored by Hospital Pablo Tobón Uribe. Completed at 1 site in Colombia. Open to participants aged 1 Month to 14 Years. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by Hospital Pablo Tobón Uribe · Not applicable, Interventional, and Treatment
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's enrollment of 92 is above the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Hospital Pablo Tobón Uribe is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Endotracheal suctioning depends on clinical manifestations
Procedure: Necessity endotracheal suctioning
Endotracheal suctioning every two hours
Procedure: Routine endotracheal suctioning
Endotracheal suctioning depends on clinical manifestations
Endotracheal suctioning every two hours
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 .
Mechanical Ventilation Length as Days.
Number of days under mechanical ventilation during ICU hospitalization length
Time frame: Every day while patient really is intubated.
| Milestone | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning |
|---|---|---|
| Started | 47 | 45 |
| Completed | 47 | 45 |
| Not completed | 0 | 0 |
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.
| event | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning |
|---|---|---|
| Primary Composite End Point | 35 | 48 |
Number of days under mechanical ventilation during ICU hospitalization length
| Days | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning |
|---|---|---|
| Mechanical Ventilation Length as Days. | 2.5 (1 to 5) | 2.4 (0.8 to 6.4) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Necessity Endotracheal Suctioning | 9/47 (19.1%) | 0/47 (0%) | 0/45 (0%) |
| Routine Endotracheal Suctioning | 12/45 (26.7%) | 1/45 (2.2%) | 0/47 (0%) |
| Event | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning |
|---|---|---|
| VAPRespiratory, thoracic and mediastinal disorders | 0/47 | 1/45 |
| Age, Continuous(months) | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning | Total |
|---|---|---|---|
| Median | 34 (7 to 104) | 56 (14 to 108) | 40.5 (8.3 to 107.1) |
| Sex: Female, Male(Participants) | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning | Total |
|---|---|---|---|
| Female | 21 | 23 | 44 |
| Male | 26 | 22 | 48 |
| Weight(Kgs) | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning | Total |
|---|---|---|---|
| Median | 15 (7 to 31) | 15 (10 to 30) | 15 (7.6 to 30) |
| PRISM(units on a scale) | Necessity Endotracheal Suctioning | Routine Endotracheal Suctioning | Total |
|---|---|---|---|
| Median | 23 (14 to 28) | 23 (17 to 27) | 23 (15 to 26.5) |
Plan to share: No
The record gives a start of Feb 2010, a primary completion of Aug 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2017, 7 years 1 month after primary completion.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Hospital Pablo Tobón Uribe