NCT01598246

Brief Summary

This is a prospective chart review of all extubations in the pediatric intensive care unit. Over a one year period all extubations in the unit are to be recorded on a designated form and standard variables charted and compared. All data will be collected from the chart, retrospectively after the extubation event. Patients who fail extubation will be compared to those who succeed. We aim to identify factors which contribute to extubation failures in the unit, to come up with a unit specific extubation policy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

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

May 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2013

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

May 11, 2012

Last Update Submit

March 29, 2018

Conditions

Keywords

Extubation failuresSedation

Study Arms (2)

Extubation Success

Patients who do not require re-intubation, upto 72 hours after a planned extubation in the pediatric intensive care unit.

Extubation failure

Patients who required re-intubation within 72 hours after a planned extubation in pediatric intensive care unit. To be further classified as early \<12 hour and late 12-72 hour, extubation failures.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children aged 0 to 18 years, admitted in pediatric intensive care unit and required intubation and mechanical ventilation.

You may qualify if:

  • All planned extubations in pediatric Intensive care unit

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical center

The Bronx, New York, 10467, United States

Location

Study Officials

  • Sandeep Tripathi, M.D

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2012

First Posted

May 15, 2012

Study Start

May 1, 2012

Primary Completion

June 30, 2013

Study Completion

June 30, 2013

Last Updated

April 2, 2018

Record last verified: 2018-03

Locations