Enteral Nutrition
Conditions
Keywords
feeding tube, coretrak, tube migration, critical care, enteral nutrition, gastric tube feeding
Brief summary
The proposed study will use an electromagnetic placement device (EMPD), Cortrak\* 2 Enteral Access System (EAS™), Avanos Medical, to verify feeding tube (FT) position on a daily basis to assess for migration. The EMPD provides real-time FT placement data. A sensor located on the distal end of the FT guidewire communicates with a receiver unit which sits on the patient's abdomen. Three visual insertion tracings with varying views (anterior, lateral, and depth/cross-section) can be saved and printed for comparison.
Detailed description
Two previous studies have been completed with similar methodology. A pilot study of 50 subjects was performed using the original Cortrak\* (2 insertion views) and found only minimal forward migration. No reverse migration was reported in one study. A pilot study of 20 patients with 62 feeding tube assessment identified 8 migration events (5 retrograde and 3 forward), these events only occurred within the small bowel. Based on this data, a recommendation could be made that there is no need to check feeding tube placement routinely every four hours. However, due to the small sample size, additional research is needed to confirm this finding. It is also unknown if there may be more migration with positioning changes, for example, up in the chair or prone position. The proposed study will use an electromagnetic placement device (EMPD), Cortrak\* 2 Enteral Access System (EAS™), Avanos Medical, to verify FT position on a daily basis to assess for migration. The proposed study will take place in critical care units at Parkview Health. The primary aim will be to determine if replication of the pilot study results in similar findings. Investigators will also explore other factors that may be associated with FT migration, such as patient mobility (ambulation or sitting at bedside or prone position) and transporting out of the critical care unit for diagnostic procedures. Researchers anticipate that results from this study will provide a better understanding of FT position and migration over time and ultimately influence recommendations for practice for frequency of routine FT verification. Standard of care for assessing feeding tube placement location every 4 hours will remain in place. The study will add an additional assessment for feeding tube location daily. This study will expand on the findings from the initial pilot study with a larger sample size.
Interventions
DEVICEelectromagnetic placement device
Daily use of an EMPD to verify FT position
Sponsors
Parkview Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
longitudinal, repeated measures design replication study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult critical care patients with small bore feeding tube inserted within last 24-48 hours * Initial Cortrak insertion tracings: all 3 views available * Cortrak guidewire available
Exclusion criteria
* Unable to speak or understand English language * Pregnancy * Prisoners * FT anticipated to be removed within 24 hours * Contraindications to placing a mark on the abdomen for top foot of receiver unit (large dressings, open abdomen, halo vest, etc.) * Original guidewire unavailable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of ETT Extubation on FT Movement | 5 days or until FT removed, whichever came first | Number of participants with clincially significant retrograde migration after extubation |
| Tube Migration | 5 days or until FT removed, whichever came first | Number of participants with clincially significant feeding tube retrograde migration |
Countries
United States
Participant flow
Pre-assignment details
One patient was removed due to a missing feeding tube stylet.
Participants by arm
| Arm | Count |
|---|---|
| Feeding Tube Migration Use of an EMPD to assess for FT migration in all eligible critical care patients requiring the use of a feeding tube during admission.
electromagnetic placement device: Daily use of an EMPD to verify FT position | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | no usable migration data for minimum of one day | 11 |
Baseline characteristics
| Characteristic | Feeding Tube Migration | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 58 Participants | — |
| Age, Categorical Between 18 and 65 years | 50 Participants | — |
| Age, Continuous | 63.92 years STANDARD_DEVIATION 13.99 | — |
| BMI | 30.96 kg/m2 STANDARD_DEVIATION 8.42 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 108 participants | — |
| Sex: Female, Male Female | 47 Participants | — |
| Sex: Female, Male Male | 61 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 119 |
| other Total, other adverse events | 0 / 119 |
| serious Total, serious adverse events | 0 / 119 |
Outcome results
Primary
Effect of ETT Extubation on FT Movement
Number of participants with clincially significant retrograde migration after extubation
Time frame: 5 days or until FT removed, whichever came first
Population: Total number of participants in study (n=108) who were intubated 30/108.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Feeding Tube Migration | Effect of ETT Extubation on FT Movement | 2 Participants |
Primary
Tube Migration
Number of participants with clincially significant feeding tube retrograde migration
Time frame: 5 days or until FT removed, whichever came first
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Feeding Tube Migration | Tube Migration | 6 Participants |