Endotracheal Tube PositionNCT02407158
Pilot Study for Verifying Endotracheal Tube Repositioning Using Ultrasound
An observational study of Endotracheal Tube Position, run by Yale University at 1 site in United States.
Trial summary
The investigators will compare the response to oral endotracheal tube repositioning as measured by chest x-ray and measured by the air-wave device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Tube Position
- What is being tested?
- SonarMed Airwave Device
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 5 Jan 2018
- 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: Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians.
Who may be able to join
- Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians.
Who cannot join
- Based on manufacturer restrictions, patients with ETTs smaller than 6.5mm and larger than 9mm, double lumen ETTs, and those patients receiving Heliox therapy will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: A Pilot Study to Explore Alternative Methods for Verifying Endotracheal Tube Repositioning in the Surgical Intensive Care Unit
The investigators will compare the response to oral endotracheal tube repositioning as measured by chest x-ray and measured by the air-wave device.
Read the detailed description
Patients This prospective, non-randomized observational study will be conducted in the Surgical Intensive Care Unit (SICU) at Yale-New Haven Hospital. As this is a pilot study to determine the accuracy and precision of the SonarMed® AirWave™ monitor, the investigators have based our projected enrollment population to complete the study within one year. Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians (attending physicians, residents, respiratory therapists, and registered nurses). Based on manufacturer restrictions, patients with ETTs smaller than 6.5mm and larger than 9mm, double lumen ETTs, and those patients receiving Heliox therapy will be excluded from this study.
Study Procedures Once the patient is identified by a member of the clinical care team, this will be communicated to the research team.
A member of the research team will verify eligibility for the study, and then place the sensor and monitoring device into the airway circuit. The monitor is placed at the end of the endotracheal tube, in-line with the ventilator circuit.
Once the required distance for ETT repositioning is prescribed, the respiratory therapist will move the ETT based on the positioning at the incisors. This is standard practice. The device readings will be recorded pre- and post-repositioning. The therapist will be blinded to the device readings. The readings taken from the AirWave monitor are for research purposes only, and will not be considered when making clinical care decisions. Following repositioning, it is standard practice to obtain a follow up chest X-ray for confirmation of tube position within a two hour window. The same head positioning, noted on the original X-ray, will be maintained for the follow up X-ray. Device readings will also be taken at the time of the follow up X-ray. If the tube is to be further repositioned based on the decisions of the SICU team the device will be left in place until such time as the tube position has been fully optimized by the SICU team.
The ETT movement recorded by the AirWave™ monitoring device will be compared with the position change indicated on the chest X-ray. Once this has been completed, the monitor will be discontinued and removed.
For this study, additional data will be recorded: name, hospital record number, age, height, weight, gender, race, prior medical history, reason for SICU admission, reason for intubation, complications due to mechanical ventilation, days on mechanical ventilation (number of days prior to repositioning procedure and total number of days), length of stay, vital signs pre- and post-repositioning, including oxygen saturation, FiO2, and any peri-procedural vital sign abnormalities.
- Conditions
- Endotracheal Tube Position
- Being tested
- SonarMed Airwave Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonarMed Airwave DeviceDevice
Measure the concordance of chest x-ray and the Airwave device for measuring the change of position of an endotracheal tube.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between tube position measured by chest x-ray and the Air-Wave Device
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startMay 2015
- Primary completion5 Jan 2018
- Study completion5 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Tube PositionStudies of the same condition, open and under way.
- More trials run by Yale 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly A Davis, MD, MBA, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407158
- Sponsor's protocol ID
- 1502015336
- Status last verified
- Jan 2018
- First submitted
- 30 Mar 2015
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Explore Alternative Methods for Verifying Endotracheal Tube Repositioning in the Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02407158
- Acronym / sponsor ID
- 1502015336
- Conditions
- Endotracheal Tube Position
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 2 Apr 2015 (estimated)
- 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 investigators will compare the response to oral endotracheal tube repositioning as measured by chest x-ray and measured by the air-wave device.
Detailed description
Patients This prospective, non-randomized observational study will be conducted in the Surgical Intensive Care Unit (SICU) at Yale-New Haven Hospital. As this is a pilot study to determine the accuracy and precision of the SonarMed® AirWave™ monitor, the investigators have based our projected enrollment population to complete the study within one year. Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians (attending physicians, residents, respiratory therapists, and registered nurses). Based on manufacturer restrictions, patients with ETTs smaller than 6.5mm and larger than 9mm, double lumen ETTs, and those patients receiving Heliox therapy will be excluded from this study.
Study Procedures Once the patient is identified by a member of the clinical care team, this will be communicated to the research team.
A member of the research team will verify eligibility for the study, and then place the sensor and monitoring device into the airway circuit. The monitor is placed at the end of the endotracheal tube, in-line with the ventilator circuit.
Once the required distance for ETT repositioning is prescribed, the respiratory therapist will move the ETT based on the positioning at the incisors. This is standard practice. The device readings will be recorded pre- and post-repositioning. The therapist will be blinded to the device readings. The readings taken from the AirWave monitor are for research purposes only, and will not be considered when making clinical care decisions. Following repositioning, it is standard practice to obtain a follow up chest X-ray for confirmation of tube position within a two hour window. The same head positioning, noted on the original X-ray, will be maintained for the follow up X-ray. Device readings will also be taken at the time of the follow up X-ray. If the tube is to be further repositioned based on the decisions of the SICU team the device will be left in place until such time as the tube position has been fully optimized by the SICU team.
The ETT movement recorded by the AirWave™ monitoring device will be compared with the position change indicated on the chest X-ray. Once this has been completed, the monitor will be discontinued and removed.
For this study, additional data will be recorded: name, hospital record number, age, height, weight, gender, race, prior medical history, reason for SICU admission, reason for intubation, complications due to mechanical ventilation, days on mechanical ventilation (number of days prior to repositioning procedure and total number of days), length of stay, vital signs pre- and post-repositioning, including oxygen saturation, FiO2, and any peri-procedural vital sign abnormalities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians.
Key inclusion criteria (1 listed)
- Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians.
Key exclusion criteria (1 listed)
- Based on manufacturer restrictions, patients with ETTs smaller than 6.5mm and larger than 9mm, double lumen ETTs, and those patients receiving Heliox therapy will be excluded from this study.
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 |
|---|---|---|
| SonarMed Airwave DeviceMeasure the concordance of chest x-ray and the Airwave device for measuring the change of position of an endotracheal tube. | Device | – |
Primary outcome
Correlation between tube position measured by chest x-ray and the Air-Wave Device
Time frame: 1 hour
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
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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.
Kimberly A Davis, MD, MBA study chair
Yale 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 Endotracheal Tube Position, run by Yale 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 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: stopped early, as of the sponsor's last update on 11 Jan 2018. 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 was stopped early. Results are not available in the source record.
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?
Correlation between tube position measured by chest x-ray and the Air-Wave Device (time frame: 1 hour). 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 11 Jan 2018.