Laryngotracheal StenosisNCT03222869
Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery
An observational study of Laryngotracheal Stenosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to determine the resistance across stenosis in the airway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngotracheal Stenosis
- What is being tested?
- Measure Airway Resistance Across Stenosis
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2017to 31 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that require outpatient endoscopic laryngeal airway surgery in the operating room.
Who may be able to join
- Patients 18 years or older that require outpatient endoscopic laryngeal airway surgery, in the operating room, at a tertiary academic center.
Who cannot join
- Pregnancy (status will be determined by a urine test as part of standard clinical care in the preoperative setting)
- Patients that are not cleared for surgery by the preoperative evaluation
- Patients with severe laryngotracheal stenosis
- Patients who are morbidly obese (BMI > 40)
- Patients with lung disease (asthma, COPD)
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to determine the resistance across stenosis in the airway.
Read the detailed description
There is significant utility in objectively measuring airflow as subjects, undergoing endoscopic laryngeal surgery, commonly have difficulties with airflow secondary to their stenosis. Easier and quicker quantification will tailor diagnosis and treatment. In order to obtain an objective measure of airflow in these participants, we will place a 20-gauge angiocatheter needle into the airway. The catheter will be in situ for a short duration during several spontaneous and non-spontaneous breaths. This will be achieved via the existing tracheostomy stoma or percutaneously via the cricothyroid membrane. This technique is commonly used to access the muscles of the larynx, however, the primary purpose will be to measure airflow in this setting.
- Conditions
- Laryngotracheal Stenosis
- Being tested
- Measure Airway Resistance Across Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure Airway Resistance Across StenosisDiagnostic test
Measure pressure and air flow Across Stenosis
| Study group | Role | What they receive |
|---|---|---|
| Laryngotracheal Stenosis | Patients with laryngotracheal stenosis will have pressure sensors placed proximal and distal to the stenosis. Pressure and air flow will be measured Receives: Diagnostic Test: Measure Airway Resistance Across Stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure (cm H20)
Using a pressure gauge to measure pressure at locations in the airway
Measured: Up to One Year
Secondary outcomes (1)
Flow Rate (L/min)
using a flow sensor to measure low rate at locations in airway
Measured: Up to One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start29 Mar 2017
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngotracheal StenosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Hillel, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222869
- Sponsor's protocol ID
- IRB00096150
- Status last verified
- Oct 2023
- First submitted
- 18 Jul 2017
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery
- ClinicalTrials.gov ID
- NCT03222869
- Acronym / sponsor ID
- IRB00096150
- Conditions
- Laryngotracheal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 Jul 2017 (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.
This research is being done to determine the resistance across stenosis in the airway.
Detailed description
There is significant utility in objectively measuring airflow as subjects, undergoing endoscopic laryngeal surgery, commonly have difficulties with airflow secondary to their stenosis. Easier and quicker quantification will tailor diagnosis and treatment. In order to obtain an objective measure of airflow in these participants, we will place a 20-gauge angiocatheter needle into the airway. The catheter will be in situ for a short duration during several spontaneous and non-spontaneous breaths. This will be achieved via the existing tracheostomy stoma or percutaneously via the cricothyroid membrane. This technique is commonly used to access the muscles of the larynx, however, the primary purpose will be to measure airflow in this setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laryngotracheal Stenosis | – | Diagnostic Test: Measure Airway Resistance Across StenosisPatients with laryngotracheal stenosis will have pressure sensors placed proximal and distal to the stenosis. Pressure and air flow will be measured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that require outpatient endoscopic laryngeal airway surgery in the operating room.
Key inclusion criteria (1 listed)
- Patients 18 years or older that require outpatient endoscopic laryngeal airway surgery, in the operating room, at a tertiary academic center.
Key exclusion criteria (5 listed)
- Pregnancy (status will be determined by a urine test as part of standard clinical care in the preoperative setting)
- Patients that are not cleared for surgery by the preoperative evaluation
- Patients with severe laryngotracheal stenosis
- Patients who are morbidly obese (BMI > 40)
- Patients with lung disease (asthma, COPD)
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 |
|---|---|---|
| Measure Airway Resistance Across StenosisMeasure pressure and air flow Across Stenosis | Diagnostic test | Laryngotracheal Stenosis |
Primary outcome
Pressure (cm H20)
Time frame: Up to One Year
Using a pressure gauge to measure pressure at locations in the airway
1 secondary outcome
Flow Rate (L/min)
Time frame: Up to One Year
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 13 Oct 2023.
Related trials for Laryngotracheal Stenosis
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
Not yet recruitingObservational study
Voice Quality Analysis of Patients With Laryngotracheal Stenosis
Idiopathic Subglottic Tracheal Stenosis
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.
Alexander Hillel, MD principal investigator
Johns Hopkins University
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 Laryngotracheal Stenosis, run by Johns Hopkins University 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 1 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 13 Oct 2023. 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?
Pressure (cm H20) (time frame: Up to One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2023.