Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05298774 |
| Other study ID # |
2000032548 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
September 1, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech
Wireless Patch System correlate with clinical markers of postoperative recovery such as
passage of flatus/bowel movement, oral tolerance of diet and discharge readiness.
Subsequently the data will be studied to establish which information in the signals is
important in determining when to feed patients and possibly discharge them.
These pilot prospective, open clinical studies suggests that myoelectrical activity, measured
on the abdominal surface with a noninvasive wireless patch system, carries predictive value
in determining time to feeding and time to flatus following open abdominal surgery. Having
such information in advance of clinical measures could facilitate timely interventions, be it
early feeding or delaying feeding as dictated by the patient's unique recovery profile. The
G-Tech Wireless Patch System would provide a unique insight into the process allowing for a
tailored protocol that could improve patient satisfaction and optimize recovery. The system
could also enable feedback on the impact to the overall gastrointestinal myoelectrical
activity of medications, particularly opioids, used for pain management that are known to
inhibit gastrointestinal function by disrupting the normal recovery patterns of colonic
motility.23-25 While it remains to be seen, in addition to predicting time to flatus/bowel
movement early on, the ability to continue monitoring the patient may allow one to predict
onset of secondary complications, such as wound infections or anastomotic leaks, that are
associated with ileus. Similarly, given the wireless noninvasive nature of the system the
patients could be discharged home with the patches, whereby they would serve as a remote
monitoring tool. This could be particularly useful in cases where the patients may have been
discharged early and may be at a high risk for readmission. The system would then send
updates/alerts to the care team for management and potentially avoid preventable
readmissions.
Description:
Gastrointestinal recovery after any visceral surgery is a complex dynamic process with
multiple factors ranging from complexity of the surgery, degree of bowel handling and
preoperative comorbidities affecting whether the recovery happens over few days, or is a slow
prolonged affair lasting weeks. Delays in the gastrointestinal recovery process or ileus is
accompanied by distention of the abdomen, pain, nausea, vomiting and the inability to
tolerate oral feeding. Interventions to alleviate the ileus/distention include insertion or
reinsertion of a nasogastric tube, instating nil per os and, if necessitated, parenteral
nutrition. All of these factors contribute not only to patient discomfort, but extend length
of stay (LOS), increase hospital resource utilization and thereby add to overall costs.
Clinically, the markers of gastrointestinal recovery are noted by passage of flatus,
defecation and the ability to tolerate solid food without significant nausea and vomiting.
Passage of stool or flatus - considered a surrogate for intestinal and anastomotic continuity
- is often used as the trigger to start stepwise dietary orders with the patient's ability to
tolerate each step marking their readiness for the subsequent meal. Fast-track and Enhanced
Recovery After Surgery (ERAS) programs that promote early feeding in advance of these
clinical markers, along with opioid sparing techniques and use of minimally invasive
procedures have been shown to be safe and beneficial for many patients by demonstrating
earlier recovery and shorter length of stay. However, it has also been shown that, for as
many as 25% of cases, the strategy does not work as noted earlier, with the need for
reinsertion of the nasogastric tube and reinstating nil per os status. In a recent study of
513 consecutive colorectal patients who were on an ERAS protocol, 128 patients (24.7%) needed
postoperative reinsertion of nasogastric tube at the 3.9±2.9 postoperative day. This suggests
that, while early postoperative feeding is beneficial to patients in whom recovery is on
track, it does not work in cases where patients are not ready for it.
At present, there is no reliable measurement that can predict gastrointestinal recovery/diet
readiness for patients in advance of these clinical markers that may allow for interventions
or fast-track programs to facilitate timely recovery. Auscultation for return of bowel
sounds, long part of the standard of care, is controversial in its usefulness to indicate
recovery. Bowel sounds have shown to have poor correlation with flatus/defecation and have
proved unsuccessful in guiding diet interventions.
Smooth muscle electrical activity on the other hand is directly related to gastrointestinal
function and motility. Researchers have previously shown a 1:1 correlation between electrical
and mechanical (contractile) events in the colon with internally placed electrode-strain
gauge force transducers. Electrical activity in the colon has been reported across a wide
range of frequencies ranging from 0 to 40 cycles per min (cpm)). Condon et. al have
documented the progressive return of colonic electrical related to resolution of
postoperative ileus and clinical recovery following surgery. These measurements have been
performed using electrodes placed internally during surgery, a major impediment towards
broader use of such technology.
G-Tech Medical has developed a noninvasive wireless patch system that measures electrical
activity from the gastrointestinal smooth muscles on the abdominal surface. This technology
has been studied as part of several non-significant risk IRB approved studies in both adults
and pediatric populations to evaluate the patterns of gastrointestinal myoelectrical signals
following surgery. The studies demonstrate that signals measured by the G-Tech Wireless
patches correlate with clinical markers of postoperative recovery such as time to feeding and
time to flatus following pancreaticoduodenectomy and general abdominal surgeries
respectively. The study in patients undergoing pancreaticoduodenectomy procedures was
conducted in collaboration with researchers at Stanford University. The study demonstrated
that measurement of gastric activity beginning immediately after pancreaticoduodenectomy with
the G-Tech Wireless Patch System, based on the measured spectral peak near 3 cpm, could
distinguish patients with shorter or longer times to diet readiness. The study demonstrated
the potential utility of the G-Tech Patch System in providing objective data to identify
patients who are progressing as well as, or better than expected, and those who are at risk
for delayed gastric emptying. In another open, prospective study, researchers examined the
use of the G-Tech Wireless Patch System in predicting time to first flatus by looking at
colonic myoelectrical activity following general abdominal surgeries.21 Patients with early
flatus had stronger early colonic activity than patients with late flatus. At 36 h
post-surgery, a linear fit of time to flatus vs cumulative colonic myoelectrical activity
predicted first flatus as much as 5 days (± 22 h) before occurrence.
These pilot prospective, open clinical studies suggests that myoelectrical activity, measured
on the abdominal surface with a noninvasive wireless patch system, carries predictive value
in determining time to feeding and time to flatus following open abdominal surgery. Having
such information in advance of clinical measures could facilitate timely interventions, be it
early feeding or delaying feeding as dictated by the patient's unique recovery profile. The
G-Tech Wireless Patch System would provide a unique insight into the process allowing for a
tailored protocol that could improve patient satisfaction and optimize recovery. The system
could also enable feedback on the impact to the overall gastrointestinal myoelectrical
activity of medications, particularly opioids, used for pain management that are known to
inhibit gastrointestinal function by disrupting the normal recovery patterns of colonic
motility. While it remains to be seen, in addition to predicting time to flatus/bowel
movement early on, the ability to continue monitoring the patient may allow one to predict
onset of secondary complications, such as wound infections or anastomotic leaks, that are
associated with ileus. Similarly, given the wireless noninvasive nature of the system the
patients could be discharged home with the patches, whereby they would serve as a remote
monitoring tool. This could be particularly useful in cases where the patients may have been
discharged early and may be at a high risk for readmission. The system would then send
updates/alerts to the care team for management and potentially avoid preventable
readmissions.
The purpose of the Phase 1 study is to determine if the myoelectrical measurements made by
the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery
such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness.
Subsequently the data will be studied to establish which information in the signals is
important in determining when to feed patients and possibly discharge them.
