Pilot Study for Verifying Endotracheal Tube Repositioning Using Ultrasound

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.

Study Overview

• Status: Terminated
• Conditions: Endotracheal Tube Position
• Intervention / Treatment: Device: SonarMed Airwave 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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between tube position measured by chest x-ray and the Air-Wave Device	1 hour

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Study Chair: Kimberly A Davis, MD, MBA, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): January 5, 2018
• Study Completion (Actual): January 5, 2018

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1502015336