Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02407158 |
| Other study ID # |
1502015336 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
March 30, 2015 |
| Last updated |
January 9, 2018 |
| Start date |
May 2015 |
| Est. completion date |
January 5, 2018 |
Study information
| Verified date |
January 2018 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
