NCT01069185

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

September 11, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

February 10, 2010

Results QC Date

February 24, 2017

Last Update Submit

September 4, 2017

Conditions

HypoxemiaArrhythmiasCardiac ArrestVentilator Associated Pneumonia

Keywords

Unplanned extubationLength of stay in PICULength of mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mechanical Ventilation Length as Days.

    Every day while patient really is intubated.

Study Arms (2)

Necessity endotracheal suctioning

EXPERIMENTAL

Endotracheal suctioning depends on clinical manifestations

Procedure: Necessity endotracheal suctioning

Routine endotracheal suctioning

OTHER

Endotracheal suctioning every two hours

Procedure: Routine endotracheal suctioning

Interventions

Necessity endotracheal suctioningPROCEDURE

Endotracheal suctioning depends on clinical manifestations

Necessity endotracheal suctioning
Routine endotracheal suctioningPROCEDURE

Endotracheal suctioning every two hours

Routine endotracheal suctioning

Eligibility Criteria

Age1 Month - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • High frequency ventilation mode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Location

Related Publications (1)

  • 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.

    PMID: 30104806DERIVED

MeSH Terms

Conditions

HypoxiaArrhythmias, CardiacHeart ArrestPneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesPathologic ProcessesHealthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease Attributes

Results Point of Contact

Title
Dr.Jorge Donado Research Unit Chief
Organization
Pablo Tobon Uribe Hospital
jdonado@hptu.org.co
+574459753

Study Officials

  • Gloria L Lema, MD

    Hospital Pablo Tobon Uribe

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 17, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 11, 2017

Results First Posted

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)