Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tracheostomy Change

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04105387
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Tracheostomy Procedure: Early Tracheostomy Change Not Applicable

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Timing of First Tracheostomy Change
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : February 5, 2020
Estimated Study Completion Date : February 5, 2020

Arm Intervention/treatment
No Intervention: Control Group
Tracheostomy change at day 7
Experimental: Treatment Group
Tracheostomy change at day 4
Procedure: Early Tracheostomy Change
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females age 0 to 2 years of age at the time of tracheostomy.
  2. Scheduled to undergo tracheostomy, or underwent tracheostomy and is currently postoperative day 4 or less
  3. Parental/guardian permission (informed consent)

Exclusion Criteria:

  1. 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.
  2. Previous or concomitant surgery at tracheostomy site
  3. Subjects who cannot be physically intubated orally or for whom intubation would be difficult for the experienced ears nose and throat physician
  4. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105387


Contacts
Layout table for location contacts
Contact: Steven Sobol, MD, MSc, FRCSC 2155903440 ext 43440 sobols@email.chop.edu

Locations
Layout table for location information
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Steven Sobol, MD, MSc, FRCSC    215-590-3440 ext 43440    sobols@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia

Publications:
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04105387     History of Changes
Other Study ID Numbers: 17-014348
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No