Status:
COMPLETED
Tracheostomy Change
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Tracheostomy
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
The purpose of this study is to compare outcomes of first tracheostomy change on postoperative day 4 to our current standard of care of first tracheostomy change on postoperative day 7.
Detailed Description
A "fresh tracheostomy" is a tracheostomy whose tract is not yet well formed and that has not yet been changed since the operative procedure. It is considered a "critical airway" since replacement foll...
Eligibility Criteria
Inclusion
- Males and females age 0 to 2 years of age at the time of tracheostomy.
- Scheduled to undergo tracheostomy, or underwent tracheostomy and is currently postoperative day 4 or less
- Parental/guardian permission (informed consent)
Exclusion
- Anatomical or physiological states identified preoperatively or intraoperatively that, in the investigator's judgment, raise concern over the viability of the tracheostomy tract to form within the first several days, or would otherwise increase the difficulty of performing an early tracheostomy change.
- Previous or concomitant surgery at tracheostomy site
- Subjects who cannot be physically intubated orally or for whom intubation would be difficult for the experienced ears nose and throat physician
- Subjects who cannot be mask ventilated
- Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with Institutional Review Board Policies and Procedures.
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04105387
Start Date
August 14 2017
End Date
February 19 2021
Last Update
March 9 2021
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104