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Completed

NCT Number: NCT04105387

Tracheostomy Change

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.

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Key information

Conditions

Age range

0 year–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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 following dislodgement may be difficult and at risk of forming a false tract. Thus, an infant or a child with a fresh tracheostomy is cared for in the intensive care unit and kept sedated to prevent accidental dislodgement. During this time wound care is often suboptimal due to fear of manipulating the neck. Patients are at increased risk of complications such as pressure ulcers and pneumonia related to being sedated for an extended length of time. Furthermore, prolonged sedation can lead to difficulties with withdrawal and delay recovery. Progression of the patient's care and the teaching of tracheostomy care to caregivers is also delayed. Thus, timing of the first tracheostomy change has great implications for prevention of complications as well as length of hospital stay. While in adults is it accepted that the first trach change can be done as early as post-operative day 3. In pediatrics no good evidence or clear guidelines is available as to when the first tracheostomy change should occur. It is common to wait until days 5-7 which allows establishment of a mature tract however, there is no biologic reason to think that a pediatric tracheostomy tract should take any longer to epithelize than in an adult. Several studies have reported safe tracheostomy change in pediatric patients as early as postoperative day 3 (Deutsch 1998, Lippert 2014, Van Buran 2014). Currently at CHOP our standard of care is to perform the first tracheostomy change on post-operative day 7. The investigators aim to compare tracheostomy tube change at post-operative day 4 by randomizing patients undergoing tracheostomy at CHOP to day 4 (treatment) or day 7 (control) groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Early Tracheostomy Change

Procedure

The treatment group will have the first tracheostomy change on postoperative day 4 by an Otolaryngology physician (attending or fellow) on the study team.

Primary outcomes

  1. Difference in complication rates between tracheostomy change group subjects

    Time frame: 6 weeks

    This will be evaluated by analyzing a difference in proportions between the "day 4" group and "day 7" group for tracheostomy changes. This will be analyzed during the study participation, regardless of which group the subjects belong to. The analysis will be conducted using two-samples tests for difference in proportions between two study groups, using a two-sided chi-square test at significance level of 0.05.

Secondary outcomes

  1. The difference in length of ICU stay between change group subjects

    Time frame: 6 weeks

    The analyses will use two-sample t-test or Mann-Whitney (as appropriate) test to compare the length of ICU/hospital stay between "day 4" group and "day 7" group subjects. This will be analyzed during the study participation, regardless of which group the subjects belong to.

  2. The difference in duration of sedation between change group subjects

    Time frame: 6 weeks

    The analyses will use two-sample t-test or Mann-Whitney (as appropriate) test to compare the duration of sedation between "day 4" group and "day 7" group subjects. This will be analyzed during the study participation, regardless of which group the subjects belong to.

  3. The difference in the amount of time for parent/caregiver education between change subjects

    Time frame: 6 weeks

    The analyses will use two-sample t-test or Mann-Whitney (as appropriate) test to compare the the amount of time for parent/caregiver education between "day 4" group and "day 7" group subjects. This will be analyzed during the study participation, regardless of which group the subjects belong to.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

Timing of First Tracheostomy Change

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2019
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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