Expired Study
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New Haven, Connecticut 06520


Purpose:

The investigators will compare the response to oral endotracheal tube repositioning as measured by chest x-ray and measured by the air-wave device.


Study summary:

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.


Criteria:

Inclusion Criteria: - Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians. Exclusion Criteria: - 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 is Available At:


Original ID:

1502015336


NCT ID:

NCT02407158


Secondary ID:


Study Acronym:


Brief Title:

Pilot Study for Verifying Endotracheal Tube Repositioning Using Ultrasound


Official Title:

A Pilot Study to Explore Alternative Methods for Verifying Endotracheal Tube Repositioning in the Surgical Intensive Care Unit


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Yale University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kimberly A Davis, MD, MBA
Study Chair
Yale School of Medicine

Study Dates

Start Date:May 2015
Completion Date:January 5, 2018
Completion Type:Actual
Primary Completion Date:January 5, 2018
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:January 9, 2018
First Received Date:March 30, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Correlation between tube position measured by chest x-ray and the Air-Wave Device
Time Frame:1 hour
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:SonarMed Airwave Device
Description:Measure the concordance of chest x-ray and the Airwave device for measuring the change of position of an endotracheal tube.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Yale University

Samples and Retentions

Study Population: Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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