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Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning

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ClinicalTrials.gov Identifier: NCT01069185
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Gloria Lema, Hospital Pablo Tobón Uribe

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

Condition or disease Intervention/treatment Phase
Hypoxemia Arrhythmias Cardiac Arrest Ventilator Associated Pneumonia Procedure: Necessity endotracheal suctioning Procedure: Routine endotracheal suctioning Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Necessity endotracheal suctioning
Endotracheal suctioning depends on clinical manifestations
Procedure: Necessity endotracheal suctioning
Endotracheal suctioning depends on clinical manifestations
Routine endotracheal suctioning
Endotracheal suctioning every two hours
Procedure: Routine endotracheal suctioning
Endotracheal suctioning every two hours



Primary Outcome Measures :
  1. Primary Composite End Point [ 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 . ]
    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 :
  1. Mechanical Ventilation Length as Days. [ Time Frame: Every day while patient really is intubated. ]
    Number of days under mechanical ventilation during ICU hospitalization length



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Ages Eligible for Study:   1 Month to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • High frequency ventilation mode

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069185


Locations
Colombia
Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Hospital Pablo Tobón Uribe
Investigators
Principal Investigator: Gloria L Lema, MD Hospital Pablo Tobon Uribe

Responsible Party: Gloria Lema, MD, Hospital Pablo Tobón Uribe
ClinicalTrials.gov Identifier: NCT01069185     History of Changes
Other Study ID Numbers: 5100-66779
First Posted: February 17, 2010    Key Record Dates
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gloria Lema, Hospital Pablo Tobón Uribe:
Unplanned extubation
Length of stay in PICU
Length of mechanical ventilation

Additional relevant MeSH terms:
Pneumonia
Heart Arrest
Pneumonia, Ventilator-Associated
Hypoxia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Heart Diseases
Cardiovascular Diseases
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Signs and Symptoms, Respiratory
Signs and Symptoms