Back to resultsDifferences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning
Primary Purpose
Hypoxemia, Arrhythmias, Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Necessity endotracheal suctioning
Routine endotracheal suctioning
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxemia focused on measuring Unplanned extubation, Length of stay in PICU, Length of mechanical ventilation
Eligibility Criteria
Inclusion Criteria:
- Children older than 1 month until 14 years old requiring orotracheal intubation
Exclusion Criteria:
- High frequency ventilation mode
Sites / Locations
- Hospital Pablo Tobon Uribe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Necessity endotracheal suctioning
Routine endotracheal suctioning
Arm Description
Endotracheal suctioning depends on clinical manifestations
Endotracheal suctioning every two hours
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mechanical Ventilation Length as Days.
Number of days under mechanical ventilation during ICU hospitalization length
Full Information
NCT ID
NCT01069185
First Posted
February 10, 2010
Last Updated
September 4, 2017
Sponsor
Hospital Pablo Tobón Uribe
1. Study Identification
Unique Protocol Identification Number
NCT01069185
Brief Title
Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning
Official Title
Differences in Morbidity Frequency Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning Protocol in Hospital Pablo Tobon Uribe´s Pediatric Intensive Care Unit (PICU). A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Pablo Tobón Uribe
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia, Arrhythmias, Cardiac Arrest, Ventilator Associated Pneumonia
Keywords
Unplanned extubation, Length of stay in PICU, Length of mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Necessity endotracheal suctioning
Arm Type
Experimental
Arm Description
Endotracheal suctioning depends on clinical manifestations
Arm Title
Routine endotracheal suctioning
Arm Type
Other
Arm Description
Endotracheal suctioning every two hours
Intervention Type
Procedure
Intervention Name(s)
Necessity endotracheal suctioning
Intervention Description
Endotracheal suctioning depends on clinical manifestations
Intervention Type
Procedure
Intervention Name(s)
Routine endotracheal suctioning
Intervention Description
Endotracheal suctioning every two hours
Primary Outcome Measure Information:
Title
Primary Composite End Point
Description
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 .
Secondary Outcome Measure Information:
Title
Mechanical Ventilation Length as Days.
Description
Number of days under mechanical ventilation during ICU hospitalization length
Time Frame
Every day while patient really is intubated.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children older than 1 month until 14 years old requiring orotracheal intubation
Exclusion Criteria:
High frequency ventilation mode
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria L Lema, MD
Organizational Affiliation
Hospital Pablo Tobon Uribe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30104806
Citation
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.
Results Reference
derived
Learn more about this trial
Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning
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