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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01069185
Other study ID # 5100-66779
Secondary ID
Status Completed
Phase N/A
First received February 10, 2010
Last updated September 4, 2017
Start date February 2010
Est. completion date August 2010

Study information

Verified date September 2017
Source Hospital Pablo Tobón Uribe
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 1 Month to 14 Years
Eligibility Inclusion Criteria:

- Children older than 1 month until 14 years old requiring orotracheal intubation

Exclusion Criteria:

- High frequency ventilation mode

Study Design


Intervention

Procedure:
Necessity endotracheal suctioning
Endotracheal suctioning depends on clinical manifestations
Routine endotracheal suctioning
Endotracheal suctioning every two hours

Locations

Country Name City State
Colombia Hospital Pablo Tobon Uribe Medellin Antioquia

Sponsors (1)

Lead Sponsor Collaborator
Hospital Pablo Tobón Uribe

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
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. 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 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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