Respiratory Failure
Conditions
Brief summary
The aim of this study is to verify the safety and accuracy of an FDA-approved device called the NEMO™ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted in the lungs of patients admitted to the intensive care unit. The hope is that the NEMO™ Gauge is able to properly determine the correct position of the endotracheal tube without the use of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight (68) subjects will participate in this study at three (3) study centers in the Inland Empire of Southern California, with subjects being enrolled at Loma Linda University Medical Center, Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.
Interventions
DEVICENEMO Gauge
Measurement and adjustment of endotracheal tube position by stylet.
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients ≥ 18 years of age admitted to the intensive care unit (ICU) 2. Patients who have been intubated or at high risk of being intubated, requiring confirmation of ETT position after intubation as determined by the clinical team 3. Endotracheal tube size 7.0 mm to 8.5 mm in diameter
Exclusion criteria
1. Patients with active hemoptysis 2. Patients with known tracheal or bronchial masses prior to endotracheal intubation 3. Patients with known tracheal or bronchial abnormalities requiring surgical repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Correct Endotracheal Tube Position | Immediate, post-intervention | The number of patients with correct Endotracheal tube position |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NEMO Gauge Baseline Characteristics | 69 |
| Total | 69 |
Baseline characteristics
| Characteristic | NEMO Gauge | — |
|---|---|---|
| Acute Respiratory Failure (Reason for Admission) | 52 Participants | — |
| Age, Continuous | 56.2 years STANDARD_DEVIATION 19.5 | — |
| BMI | 31 kg/m2 STANDARD_DEVIATION 13.8 | — |
| Cardiac (Reason for Admission) | 5 Participants | — |
| Endotracheal Size 7.5 mm | 41 Participants | — |
| Endotracheal Size 7 mm | 2 Participants | — |
| Endotracheal Size 8 mm | 26 Participants | — |
| Gastrointestinal (Reason for Admission) | 13 Participants | — |
| Neuromuscular (Reason for Admission) | 11 Participants | — |
| Other (Reason for Admission) | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Renal (Reason for Admission) | 5 Participants | — |
| Sepsis (Reason for Admission) | 14 Participants | — |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 47 Participants | — |
| Shock on vasopressors (Reason for Admission) | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 71 |
| other Total, other adverse events | 0 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
Primary
Number of Correct Endotracheal Tube Position
The number of patients with correct Endotracheal tube position
Time frame: Immediate, post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NEMO Gauge | Number of Correct Endotracheal Tube Position | 64 Participants |