Tracheostomy Change

NCT ID: NCT04105387

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2021-02-19

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 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.

Conditions

Tracheostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

Tracheostomy change at day 7

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment Group

Tracheostomy change at day 4

Group Type: EXPERIMENTAL

Early Tracheostomy Change

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 9821926 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25468464 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 28483242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22990518 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2029066 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25432165 (View on PubMed)

Other Identifiers

17-014348

Identifier Type: -

Identifier Source: org_study_id