TracheostomyNCT06201130
Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.
An observational study of Tracheostomy and Endotracheal Tube, run by Northwell Health at 1 site in United States.
Trial summary
Artificial airways, such as endotracheal tubes and tracheostomies, in the pediatric and neonatal intensive care units (PICU, NICU respectively) are lifesaving for patients in respiratory failure, among other conditions. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Tracheostomy, Endotracheal Tube, Ventilator Associated Pneumonia
- What is being tested?
- Suctioning of artificial airway
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to 26 Jun 2025
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects included will be children aged 0-18 years of all sexes, ethnic and racial backgrounds. Subjects will generally be ill and have many comorbid conditions, as patients with artificial airways in the PICU and NICU tend to have complex issues. There are no exclusion criteria. Children must be included as this study wishes to understand the impact of exchanging artificial airways in the pediatric population.
Who may be able to join
- All patients with tracheostomies in the pediatric or neonatal intensive care unit
- Patients with endotracheal tubes undergoing artificial airway exchange in the pediatric or neonatal intensive care unit
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cohen Children's Medical Center
Queens, New York, 11040
Evin S Feldman, MD, 718-470-3350, efeldman4@northwell.edu
About this study
Artificial airways, such as endotracheal tubes and tracheostomies, in the pediatric and neonatal intensive care units (PICU, NICU respectively) are lifesaving for patients in respiratory failure, among other conditions. These devices are not without a risk of infection - ventilator-associated infections (VAIs), namely ventilator associated pneumonia (VAP) and ventilator-associated tracheitis (VAT), are common. Treatment of suspected VAI accounts for nearly half of all Pediatric Intensive Care Unit (PICU) antibiotic use. VAI can represent a continuum from tracheal colonization, progression to tracheobronchial inflammation, and then pneumonia. Colonization of these airways is common and bacterial growth does not necessarily indicate a clinically significant infection. Tracheostomies, which are artificial airways meant for chronic use, are routinely exchanged on a semi-monthly to monthly basis, in part to disrupt bacterial biofilm formation that aids bacterial colonization and perhaps infection. When patients with tracheostomies are admitted for acute on chronic respiratory failure or a concern for an infection, these artificial airways are also routinely exchanged at some institutions. There however remains a critical need to understand how an artificial airway exchange alters the bacterial environment of these patients in sickness and in health. This research hypothesizes that exchanging an artificial airway will alter the microbiome of the artificial airway, by altering the microbial diversity and relative abundance of different bacterial species of the artificial airway. This study will involve the prospective collection of tracheal aspirates from patients with artificial airways. We will screen and enroll all patients admitted to a the NICU or PICU at Cohen Children's Medical Center (CCMC) who have tracheostomies and obtain tracheal aspirates within 72 hours before and after tracheostomy or endotracheal tube exchange. Tracheal aspirates are routinely obtained in the NICU and PICU from suctioning of an artificial airway and is a minimal risk activity. These samples will be brought to the Feinstein Institutes for Medical Research for 16 s ribosomal DNA (16srDNA) sequencing, which allows for accurate and sensitive detection of relative abundance and classification of bacterial flora. Tracheal aspirate sets will be analyzed against each other. Additionally, clinical and epidemiological data from the electronic medical record will be obtained. Antibiotic exposure will be accounted for via previously published means.
- Conditions
- Tracheostomy, Endotracheal Tube, Ventilator Associated Pneumonia, Tracheitis, Microbial Colonization, Pediatric Infectious Disease
- Being tested
- Suctioning of artificial airway
- Medical subject headings
- Pneumonia, Ventilator-Associated, Tracheitis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suctioning of artificial airwayDiagnostic test
Collection of tracheal aspirates in either the PICU or NICU will occur. We will instill 1 mL of normal saline, then perform bag ventilation, and then suction out aspirate. Suctioning is routinely performed for tracheostomy and endotracheal tube hygiene - for instance, it is performed on tracheostomies by caregivers at home. The aspirates that will be collected will be clinically indicated and otherwise would be discarded. If the patients weren't enrolled in this research, the aspirates would have been collected anyways.
What is being measured
The primary outcome is the main question the study is designed to answer.
Shannon diversity index
A measure of alpha diversity
Measured: December 2023-June 2025
Bray-curtis dissimilarity
A measure of beta diversity
Measured: December 2023-June 2025
Differential abundance
Measured: December 2023-June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start20 Dec 2023
- Primary completion26 Jun 2025 (estimated)
- Study completion26 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201130
- Sponsor's protocol ID
- IRB-23-0420
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Can share identified data
Publications
Kuhl LP, Marostica PJC, Macedo AJ, Kuhl G, Siebert M, Manica D, Sekine L, Schweiger C. High microbiome variability in pediatric tracheostomy cannulas in patients with similar clinical characteristics. Braz J Otorhinolaryngol. 2023 Mar-Apr;89(2):254-263. doi: 10.1016/j.bjorl.2022.05.001. Epub 2022 May 20.
PubMed 35680554Maffei D, Brewer M, Codipilly C, Weinberger B, Schanler RJ. Early oral colostrum administration in preterm infants. J Perinatol. 2020 Feb;40(2):284-287. doi: 10.1038/s41372-019-0556-x. Epub 2019 Nov 20.
PubMed 31748654Mitchell 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 22990518Perez-Losada M, Graham RJ, Coquillette M, Jafarey A, Castro-Nallar E, Aira M, Freishtat RJ, Mansbach JM. The temporal dynamics of the tracheal microbiome in tracheostomised patients with and without lower respiratory infections. PLoS One. 2017 Aug 10;12(8):e0182520. doi: 10.1371/journal.pone.0182520. eCollection 2017.
PubMed 28796800Perez-Losada M, Graham RJ, Coquillette M, Jafarey A, Castro-Nallar E, Aira M, Hoptay C, Freishtat RJ, Mansbach JM. Tracheal Microbiota in Patients With a Tracheostomy Before, During and After an Acute Respiratory Infection. Pediatr Infect Dis J. 2018 Nov;37(11):e269-e271. doi: 10.1097/INF.0000000000001952.
PubMed 29462107Zachariah P, Ryan C, Nadimpalli S, Coscia G, Kolb M, Smith H, Foca M, Saiman L, Planet PJ. Culture-Independent Analysis of Pediatric Bronchoalveolar Lavage Specimens. Ann Am Thorac Soc. 2018 Sep;15(9):1047-1056. doi: 10.1513/AnnalsATS.201802-146OC.
PubMed 29877714
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.
- ClinicalTrials.gov ID
- NCT06201130
- Acronym / sponsor ID
- IRB-23-0420
- Conditions
- Tracheostomy, Endotracheal Tube, Ventilator Associated Pneumonia, Tracheitis, Microbial Colonization, Pediatric Infectious Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 26 Jun 2025 (estimated)
- Study completion
- 26 Jun 2025 (estimated)
- First posted
- 11 Jan 2024 (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.
Artificial airways, such as endotracheal tubes and tracheostomies, in the pediatric and neonatal intensive care units (PICU, NICU respectively) are lifesaving for patients in respiratory failure, among other conditions. These devices are not without a risk of infection - ventilator-associated infections (VAIs), namely ventilator associated pneumonia (VAP) and ventilator-associated tracheitis (VAT), are common. Treatment of suspected VAI accounts for nearly half of all Pediatric Intensive Care Unit (PICU) antibiotic use. VAI can represent a continuum from tracheal colonization, progression to tracheobronchial inflammation, and then pneumonia. Colonization of these airways is common and bacterial growth does not necessarily indicate a clinically significant infection. Tracheostomies, which are artificial airways meant for chronic use, are routinely exchanged on a semi-monthly to monthly basis, in part to disrupt bacterial biofilm formation that aids bacterial colonization and perhaps infection. When patients with tracheostomies are admitted for acute on chronic respiratory failure or a concern for an infection, these artificial airways are also routinely exchanged at some institutions. There however remains a critical need to understand how an artificial airway exchange alters the bacterial environment of these patients in sickness and in health. This research hypothesizes that exchanging an artificial airway will alter the microbiome of the artificial airway, by altering the microbial diversity and relative abundance of different bacterial species of the artificial airway. This study will involve the prospective collection of tracheal aspirates from patients with artificial airways. We will screen and enroll all patients admitted to a the NICU or PICU at Cohen Children's Medical Center (CCMC) who have tracheostomies and obtain tracheal aspirates within 72 hours before and after tracheostomy or endotracheal tube exchange. Tracheal aspirates are routinely obtained in the NICU and PICU from suctioning of an artificial airway and is a minimal risk activity. These samples will be brought to the Feinstein Institutes for Medical Research for 16 s ribosomal DNA (16srDNA) sequencing, which allows for accurate and sensitive detection of relative abundance and classification of bacterial flora. Tracheal aspirate sets will be analyzed against each other. Additionally, clinical and epidemiological data from the electronic medical record will be obtained. Antibiotic exposure will be accounted for via previously published means.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects included will be children aged 0-18 years of all sexes, ethnic and racial backgrounds. Subjects will generally be ill and have many comorbid conditions, as patients with artificial airways in the PICU and NICU tend to have complex issues. There are no exclusion criteria. Children must be included as this study wishes to understand the impact of exchanging artificial airways in the pediatric population.
Key inclusion criteria (2 listed)
- All patients with tracheostomies in the pediatric or neonatal intensive care unit
- Patients with endotracheal tubes undergoing artificial airway exchange in the pediatric or neonatal intensive care unit
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Suctioning of artificial airwayCollection of tracheal aspirates in either the PICU or NICU will occur. We will instill 1 mL of normal saline, then perform bag ventilation, and then suction out aspirate. Suctioning is routinely performed for tracheostomy and endotracheal tube hygiene - for instance, it is performed on tracheostomies by caregivers at home. The aspirates that will be collected will be clinically indicated and otherwise would be discarded. If the patients weren't enrolled in this research, the aspirates would have been collected anyways. | Diagnostic test | – |
Primary outcome
Shannon diversity index
Time frame: December 2023-June 2025
A measure of alpha diversity
Bray-curtis dissimilarity
Time frame: December 2023-June 2025
A measure of beta diversity
Differential abundance
Time frame: December 2023-June 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 35680554Kuhl LP, Marostica PJC, Macedo AJ, Kuhl G, Siebert M, Manica D, Sekine L, Schweiger C. High microbiome variability in pediatric tracheostomy cannulas in patients with similar clinical characteristics. Braz J Otorhinolaryngol. 2023 Mar-Apr;89(2):254-263. doi: 10.1016/j.bjorl.2022.05.001. Epub 2022 May 20.
- Background: PubMed 31748654Maffei D, Brewer M, Codipilly C, Weinberger B, Schanler RJ. Early oral colostrum administration in preterm infants. J Perinatol. 2020 Feb;40(2):284-287. doi: 10.1038/s41372-019-0556-x. Epub 2019 Nov 20.
- 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 28796800Perez-Losada M, Graham RJ, Coquillette M, Jafarey A, Castro-Nallar E, Aira M, Freishtat RJ, Mansbach JM. The temporal dynamics of the tracheal microbiome in tracheostomised patients with and without lower respiratory infections. PLoS One. 2017 Aug 10;12(8):e0182520. doi: 10.1371/journal.pone.0182520. eCollection 2017.
- Background: PubMed 29462107Perez-Losada M, Graham RJ, Coquillette M, Jafarey A, Castro-Nallar E, Aira M, Hoptay C, Freishtat RJ, Mansbach JM. Tracheal Microbiota in Patients With a Tracheostomy Before, During and After an Acute Respiratory Infection. Pediatr Infect Dis J. 2018 Nov;37(11):e269-e271. doi: 10.1097/INF.0000000000001952.
- Background: PubMed 29877714Zachariah P, Ryan C, Nadimpalli S, Coscia G, Kolb M, Smith H, Foca M, Saiman L, Planet PJ. Culture-Independent Analysis of Pediatric Bronchoalveolar Lavage Specimens. Ann Am Thorac Soc. 2018 Sep;15(9):1047-1056. doi: 10.1513/AnnalsATS.201802-146OC.
- Individual participant dataSharing planned: Undecided. Can share identified data
Related trials for Tracheostomy
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
Enrolling by invitationObservational study
A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
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
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy and Endotracheal Tube, run by Northwell Health 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evin S Feldman, MD ((516) 562-3467, efeldman4@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shannon diversity index (time frame: December 2023-June 2025). The study lists 3 primary outcomes in all. 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 NCT06201130, which also lists 6 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 17 Jan 2024.