Tracheostomy Change

Completed · Not applicable

Conditions studied: Tracheostomy

In brief

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.

Key facts

Study ID

NCT04105387

Run by

Children's Hospital of Philadelphia

People needed

16

Starts

2017-08-14

Expected to finish

2021-02-19

Last updated by the study team

2021-03-09

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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