Nasogastric Tube IntubationNCT06648759
Vagal Stimulator to Reduce Nasogastric Tube Use
A study testing Vagal Nerve Stimulator in people with Nasogastric Tube Intubation, run by Jacques E. Chelly at 1 site in United States.
Trial summary
Abdominal surgery, laparoscopic or open, is frequently performed at UPMC Shadyside hospital. One of the most frequent complications following abdominal surgery is a postoperative ileus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasogastric Tube Intubation
- What is being tested?
- Vagal Nerve Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 and older) undergoing laparoscopic or open colorectal surgery, or any major abdominal surgeries at UPMC Shadyside
- Development of post-operative ileus
- Anticipation of a nasogastric (ng) tube being placed
Who cannot join
- Pregnant subjects
- Subjects who are unable to read, write, or speak English fluently
- Subjects who have a developmental or neurological disorder and are not cognitively able to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amy Monroe, MPH, MBA contact
United States1 site, 1 recruiting
- Recruiting
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Amy Monroe, MPH, MBA, 412-623-6382, monroeal@upmc.edu
Carly Riedmann, MPH, riedmannca@upmc.edu
About this study
Official title: The Role of a Vagal Stimulator to Reduce the Frequency and Duration on Nasogastric Tube Following Abdominal Surgery
Abdominal surgery, laparoscopic or open, is frequently performed at UPMC Shadyside hospital. One of the most frequent complications following abdominal surgery is a postoperative ileus. Although postoperative ileus may be the result of obstruction or leakage, in most cases postoperative ileus (POI) is the result of local irritation because of fluid overload, exogenous opioids, neurohormonal dysfunction, gastrointestinal stretch, local bleeding and inflammation. POI usually lasts between 2 to 7 days. In most cases, a nasogastric tube (NG tube) is used to relieve that gastric pressure until the resolution of the POI. The placement of a NG tube can lead to a local trauma, bleeding and pain. Pain represents a major complaint among those with POI, often contributing to prolonged hospital stays.
Read the detailed description
Abdominal surgery, laparoscopic or open, is frequently performed at UPMC Shadyside hospital. One of the most frequent complications following abdominal surgery is a postoperative ileus. Although postoperative ileus may be the result of obstruction or leakage, in most cases postoperative ileus (POI) is the result of local irritation because of fluid overload, exogenous opioids, neurohormonal dysfunction, gastrointestinal stretch, local bleeding and inflammation. POI usually lasts between 2 to 7 days. In most cases, a nasogastric tube (NG tube) is used to relieve that gastric pressure until the resolution of the POI. The placement of a NG tune can lead to a local trauma, bleeding and pain. Pain represents a major complaint among those with POI, often contributing to prolonged hospital stays.
It has been well established that bile function is modulated by the vagal nerve. Therefore, a non-invasive vagal stimulation administered post-operatively may facilitate the resolution of POI, accelerate the return to bile function and shorter the hospital length of stay following major abdominal surgery. Anecdotally, the use of a vagal nerve stimulator has been shown to avoid the placement of a NG tube.
In most cases, postoperative ileus is considered a benign and reversible complication that occurs in 10-30% of patients following abdominal surgery. The use of anesthesia, the use of opioids and anti-inflammatory drugs, hypokalemia, local inflammation, local hematoma, can all contribute to the development of a POI, and its treatment often requires the placement of a NG tube. The placement of a NG tube is not always effective if it is not positioned properly and is associated of a local trauma, misplacement of the NG tube, prolonged pain, and hospital stay. It is always very uncomfortable for the patient. Since the gastro-intestinal motility is regulated by the vagal nerve, the use of non-invasive vagal nerve stimulator may represent an interesting technique to reduce the frequency of this complications associated with the use of a nasogastric tube including local trauma, misplacement and pain on insertion, and constant pain as long as the NG tube remain in place.
- Conditions
- Nasogastric Tube Intubation
- Being tested
- Vagal Nerve Stimulator, Placebo Vagal Nerve Stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal Nerve StimulatorDevice
The vagal nerve stimulator device is a nonsignificant risk device that provides electrical impulses to the vagus nerve, located in the neck and ear regions. The device (pulse generator) and a wire lead (insulated wire) with electrodes on the end of the wire will send the electrical signals along the vagus nerve to your brainstem to activate various neurochemical coordinates.
Placebo Vagal Nerve StimulatorDevice
The sham vagal nerve stimulator device is a nonsignificant risk device that mirrors that of the active stimulator but does not provide electrical impulses to the vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Vagal Nerve Stimulator Group | Experimental | This arm of the study will be randomly assigned to receive the active vagal nerve stimulator device which is placed via electrodes on each side of the neck. The active device will experience two 45-minute sessions daily of vagal nerve stimulation until their Nasogastric (NG) tube is removed. Receives: Device: Vagal Nerve Stimulator |
| Placebo Vagal Nerve Stimulator Group | Sham comparator | This arm of the study will be randomly assigned to receive a sham device that mirrors that of the active vagal nerve stimulator devices. The sham device arm will experience two 45-minute sessions daily of placebo vagal nerve stimulation until their Nasogastric (NG) tube is removed. Receives: Device: Placebo Vagal Nerve Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of use of nasogastric (NG) tube
The duration of use of nasogastric (NG) tube will be reported as total of minutes the NG tube is placed and reported in each group as mean(SD) in minutes.
Measured: Up to 30 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start4 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasogastric Tube IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacques E. Chelly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacques E. Chelly, University of Pittsburgh
- Investigators
- Jacques E Chelly, MD, PhD, MBA, Principal investigator, University of Pittsburgh, UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648759
- Sponsor's protocol ID
- STUDY24070152
- Status last verified
- Nov 2026
- First submitted
- 16 Oct 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Vagal Stimulator to Reduce the Frequency and Duration on Nasogastric Tube Following Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06648759
- Acronym / sponsor ID
- STUDY24070152
- Conditions
- Nasogastric Tube Intubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jacques E. ChellyUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abdominal surgery, laparoscopic or open, is frequently performed at UPMC Shadyside hospital. One of the most frequent complications following abdominal surgery is a postoperative ileus. Although postoperative ileus may be the result of obstruction or leakage, in most cases postoperative ileus (POI) is the result of local irritation because of fluid overload, exogenous opioids, neurohormonal dysfunction, gastrointestinal stretch, local bleeding and inflammation. POI usually lasts between 2 to 7 days. In most cases, a nasogastric tube (NG tube) is used to relieve that gastric pressure until the resolution of the POI. The placement of a NG tube can lead to a local trauma, bleeding and pain. Pain represents a major complaint among those with POI, often contributing to prolonged hospital stays.
Detailed description
Abdominal surgery, laparoscopic or open, is frequently performed at UPMC Shadyside hospital. One of the most frequent complications following abdominal surgery is a postoperative ileus. Although postoperative ileus may be the result of obstruction or leakage, in most cases postoperative ileus (POI) is the result of local irritation because of fluid overload, exogenous opioids, neurohormonal dysfunction, gastrointestinal stretch, local bleeding and inflammation. POI usually lasts between 2 to 7 days. In most cases, a nasogastric tube (NG tube) is used to relieve that gastric pressure until the resolution of the POI. The placement of a NG tune can lead to a local trauma, bleeding and pain. Pain represents a major complaint among those with POI, often contributing to prolonged hospital stays.
It has been well established that bile function is modulated by the vagal nerve. Therefore, a non-invasive vagal stimulation administered post-operatively may facilitate the resolution of POI, accelerate the return to bile function and shorter the hospital length of stay following major abdominal surgery. Anecdotally, the use of a vagal nerve stimulator has been shown to avoid the placement of a NG tube.
In most cases, postoperative ileus is considered a benign and reversible complication that occurs in 10-30% of patients following abdominal surgery. The use of anesthesia, the use of opioids and anti-inflammatory drugs, hypokalemia, local inflammation, local hematoma, can all contribute to the development of a POI, and its treatment often requires the placement of a NG tube. The placement of a NG tube is not always effective if it is not positioned properly and is associated of a local trauma, misplacement of the NG tube, prolonged pain, and hospital stay. It is always very uncomfortable for the patient. Since the gastro-intestinal motility is regulated by the vagal nerve, the use of non-invasive vagal nerve stimulator may represent an interesting technique to reduce the frequency of this complications associated with the use of a nasogastric tube including local trauma, misplacement and pain on insertion, and constant pain as long as the NG tube remain in place.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Vagal Nerve Stimulator Group | Experimental | Device: Vagal Nerve StimulatorThis arm of the study will be randomly assigned to receive the active vagal nerve stimulator device which is placed via electrodes on each side of the neck. The active device will experience two 45-minute sessions daily of vagal nerve stimulation until their Nasogastric (NG) tube is removed. |
| Placebo Vagal Nerve Stimulator Group | Sham comparator | Device: Placebo Vagal Nerve StimulatorThis arm of the study will be randomly assigned to receive a sham device that mirrors that of the active vagal nerve stimulator devices. The sham device arm will experience two 45-minute sessions daily of placebo vagal nerve stimulation until their Nasogastric (NG) tube is removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18 and older) undergoing laparoscopic or open colorectal surgery, or any major abdominal surgeries at UPMC Shadyside
- Development of post-operative ileus
- Anticipation of a nasogastric (ng) tube being placed
Key exclusion criteria (3 listed)
- Pregnant subjects
- Subjects who are unable to read, write, or speak English fluently
- Subjects who have a developmental or neurological disorder and are not cognitively able to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagal Nerve StimulatorThe vagal nerve stimulator device is a nonsignificant risk device that provides electrical impulses to the vagus nerve, located in the neck and ear regions. The device (pulse generator) and a wire lead (insulated wire) with electrodes on the end of the wire will send the electrical signals along the vagus nerve to your brainstem to activate various neurochemical coordinates. | Device | Vagal Nerve Stimulator Group |
| Placebo Vagal Nerve StimulatorThe sham vagal nerve stimulator device is a nonsignificant risk device that mirrors that of the active stimulator but does not provide electrical impulses to the vagus nerve. | Device | Placebo Vagal Nerve Stimulator Group |
Primary outcome
Duration of use of nasogastric (NG) tube
Time frame: Up to 30 days following surgery
The duration of use of nasogastric (NG) tube will be reported as total of minutes the NG tube is placed and reported in each group as mean(SD) in minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Comparing Two Methods to Measure Nasogastric Tube Length
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Monroe, MPH, MBA contact
Jacques E Chelly, MD, PhD, MBA principal investigator
University of Pittsburgh, UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal Nerve Stimulator in people with Nasogastric Tube Intubation, run by Jacques E. Chelly at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carly Riedmann, MPH (412-623-4147, riedmannca@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of use of nasogastric (NG) tube (time frame: Up to 30 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.