Tracheostomy Change

NCT04105387 | Completed

• 1 other identifier: 17-014348
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy

Outcome Measures

Primary Outcomes (1)

• Difference in complication rates between tracheostomy change group subjects

  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.

  6 weeks

Secondary Outcomes (3)

• The difference in length of ICU stay between change group subjects

  6 weeks

• The difference in duration of sedation between change group subjects

  6 weeks

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

  6 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Tracheostomy change at day 7

Treatment Group

EXPERIMENTAL

Tracheostomy change at day 4

Procedure: Early Tracheostomy Change

Interventions

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.

Treatment Group

Eligibility Criteria

• Age: 0 Years - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

• Deutsch ES. Early tracheostomy tube change in children. Arch Otolaryngol Head Neck Surg. 1998 Nov;124(11):1237-8. doi: 10.1001/archotol.124.11.1237.

  PMID: 9821926 BACKGROUND

• Lippert D, Hoffman MR, Dang P, McMurray JS, Heatley D, Kille T. Care of pediatric tracheostomy in the immediate postoperative period and timing of first tube change. Int J Pediatr Otorhinolaryngol. 2014 Dec;78(12):2281-5. doi: 10.1016/j.ijporl.2014.10.034. Epub 2014 Nov 3.

  PMID: 25468464 BACKGROUND

• McCullagh, Peter; Nelder, John. Generalized Linear Models, Second Edition 1989. Boca Raton: Chapman and Hall/CRC.

  BACKGROUND

• McEvoy TP, Seim NB, Aljasser A, Elmaraghy CA, Ruth B, Justice L, Begue S, Jatana KR. Prevention of post-operative pediatric tracheotomy wounds: A multidisciplinary team approach. Int J Pediatr Otorhinolaryngol. 2017 Jun;97:235-239. doi: 10.1016/j.ijporl.2017.03.037. Epub 2017 Mar 31.

  PMID: 28483242 BACKGROUND

• Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18.

  PMID: 22990518 BACKGROUND

• Senders CW, Muntz HR, Schweiss D. Physician survey on the care of children with tracheotomy. Am J Otolaryngol. 1991 Jan-Feb;12(1):48-50. doi: 10.1016/0196-0709(91)90072-n.

  PMID: 2029066 BACKGROUND

• Van Buren NC, Narasimhan ER, Curtis JL, Muntz HR, Meier JD. Pediatric tracheostomy: timing of the first tube change. Ann Otol Rhinol Laryngol. 2015 May;124(5):374-7. doi: 10.1177/0003489414560430. Epub 2014 Nov 27.

  PMID: 25432165 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 26, 2019
• Study Start: August 14, 2017
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)