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Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning Protocol in Pediatric Intensive Care Unit (PICU)

This study has been completed.
Sponsor:
Information provided by:
Hospital Pablo Tobón Uribe
ClinicalTrials.gov Identifier:
NCT01069185
First received: February 10, 2010
Last updated: August 15, 2010
Last verified: August 2010
History of Changes
  Purpose

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


Condition Intervention
Hypoxemia
Unplanned Extubation
Arrhythmias
Cardiac Arrest
Ventilator Associated Pneumonia
 Procedure: Necessity endotracheal suctioning
Procedure: Routine endotracheal suctioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Pablo Tobón Uribe:

Primary Outcome Measures:
  • All causes 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mechanical ventilation length as days. [ Time Frame: Every day while patient really is intubated. ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Month to 14 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Gloria Lucía Lema/International and Transplants Support Office Chief, Hospital Pablo Tobon Uribe
ClinicalTrials.gov Identifier: NCT01069185     History of Changes
Other Study ID Numbers: 5100-66779
Study First Received: February 10, 2010
Last Updated: August 15, 2010
Health Authority: Colombia: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013