TracheostomyNCT04105387
Tracheostomy Change
A study testing Early Tracheostomy Change in people with Tracheostomy, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheostomy
- What is being tested?
- Early Tracheostomy Change
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 19 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Timing of First 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.
Read the 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
- Being tested
- Early Tracheostomy Change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Tracheostomy ChangeProcedure or surgery
The treatment group will have the first tracheostomy change on postoperative day 4 by an Otolaryngology physician (attending or fellow) on the study team.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Tracheostomy change at day 7 |
| Treatment Group | Experimental | Tracheostomy change at day 4 Receives: Procedure: Early Tracheostomy Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (3)
The difference in length of ICU stay between change group subjects
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.
Measured: 6 weeks
The difference in duration of sedation between change group subjects
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.
Measured: 6 weeks
The difference in the amount of time for parent/caregiver education between change subjects
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start14 Aug 2017
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105387
- Sponsor's protocol ID
- 17-014348
- Status last verified
- Mar 2021
- First submitted
- 23 Sep 2019
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9821926Lippert 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.
PubMed 25468464McCullagh, Peter; Nelder, John. Generalized Linear Models, Second Edition 1989. Boca Raton: Chapman and Hall/CRC.
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.
PubMed 28483242Mitchell 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.
PubMed 22990518Senders 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.
PubMed 2029066Van 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.
PubMed 25432165
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of First Tracheostomy Change
- ClinicalTrials.gov ID
- NCT04105387
- Acronym / sponsor ID
- 17-014348
- Conditions
- Tracheostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Tracheostomy change at day 7 |
| Treatment Group | Experimental | Procedure: Early Tracheostomy ChangeTracheostomy change at day 4 |
Who may qualify
- Ages
- 0 to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Tracheostomy ChangeThe treatment group will have the first tracheostomy change on postoperative day 4 by an Otolaryngology physician (attending or fellow) on the study team. | Procedure or surgery | Treatment Group |
Primary outcome
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.
3 secondary outcomes
The difference in length of ICU stay between change group subjects
Time frame: 6 weeks
The difference in duration of sedation between change group subjects
Time frame: 6 weeks
The difference in the amount of time for parent/caregiver education between change subjects
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Background: PubMed 9821926Deutsch 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.
- Background: PubMed 25468464Lippert 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.
- BackgroundMcCullagh, Peter; Nelder, John. Generalized Linear Models, Second Edition 1989. Boca Raton: Chapman and Hall/CRC.
- Background: PubMed 28483242McEvoy 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.
- Background: PubMed 22990518Mitchell 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.
- Background: PubMed 2029066Senders 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.
- Background: PubMed 25432165Van 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.
- Individual participant dataSharing planned: No
Related trials for Tracheostomy
Enrolling by invitation
No DIET Trial: Dogmatic Interruption of Enteral nuTrition
Gastrostomy, Tracheostomy
Recruiting
Classical Music, Pain, and Physiological Parameters in Children Undergoing Two Aspiration Procedures
Endotracheal Aspiration, Tracheostomy Patients
Enrolling by invitationObservational study
A Voice Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
RecruitingObservational study
Increased Body Temperature Post Tracheostomy: a Retrospective Study
Tracheostomy Complication
RecruitingObservational study
Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome
Guillain Barre Syndrome, Mechanical Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Tracheostomy Change in people with Tracheostomy, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in complication rates between tracheostomy change group subjects (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105387, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.