An interventional study of NEMO Gauge in Respiratory Failure, sponsored by Loma Linda University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by Loma Linda University · Not applicable, Interventional, and Diagnostic
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 71 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Measurement and adjustment of endotracheal tube position by stylet.
Device: NEMO Gauge
Measurement and adjustment of endotracheal tube position by stylet.
Number of Correct Endotracheal Tube Position
The number of patients with correct Endotracheal tube position
Time frame: Immediate, post-intervention
| Milestone | NEMO Gauge |
|---|---|
| Started | 71 |
| Completed | 69 |
| Not completed | 2 |
The number of patients with correct Endotracheal tube position
| Participants | NEMO Gauge |
|---|---|
| Number of Correct Endotracheal Tube Position | 64 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NEMO Gauge | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| Age, Continuous(years) | NEMO Gauge |
|---|---|
| Mean | 56.2 ± 19.5 |
| Sex: Female, Male(Participants) | NEMO Gauge |
|---|---|
| Female | 22 |
| Male | 47 |
| Race and Ethnicity Not Collected(Participants) | NEMO Gauge |
|---|
| BMI(kg/m2) | NEMO Gauge |
|---|---|
| Mean | 31 ± 13.8 |
| Acute Respiratory Failure (Reason for Admission)(Participants) | NEMO Gauge |
|---|---|
| Count of participants | 52 |
| Sepsis (Reason for Admission)(Participants) | NEMO Gauge |
|---|---|
| Count of participants | 14 |
| Gastrointestinal (Reason for Admission)(Participants) | NEMO Gauge |
|---|---|
| Count of participants | 13 |
| Neuromuscular (Reason for Admission)(Participants) | NEMO Gauge |
|---|---|
| Count of participants | 11 |
7 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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