GastrostomyNCT06431048
No DIET Trial: Dogmatic Interruption of Enteral nuTrition
A study testing Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure. and Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure. in people with Gastrostomy and Tracheostomy, run by Jeffrey Coughenour at 1 site in United States.
Trial summary
There is currently limited guidance on when to hold nutritional supplementation through for patients, who are receiving tube feeding, undergoing surgical procedures. This study aims to investigate which time would be the best to stop nutrition, if at all, before undergoing a surgical procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrostomy, Tracheostomy
- What is being tested?
- Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure. and Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to Dec 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
- Patients aged >18 years.
- Patients who require a tracheostomy or PEG placement.
Who cannot join
- Patients with gastric and/or bowel obstruction.
- Patients unable to receive enteral nutrition.
- Patients who are pregnant and/or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Missouri Hospital
Columbia, Missouri, 65212
About this study
There is currently limited guidance on when to hold nutritional supplementation through for patients, who are receiving tube feeding, undergoing surgical procedures. This study aims to investigate which time would be the best to stop nutrition, if at all, before undergoing a surgical procedure.
Read the detailed description
The risk for malnutrition-associated complications is high for patients in the trauma- surgical-, and neurological intensive care units. Patients with persistent neurologic impairment often require nutritional supplementation through a variety of naso-enteral or surgical feeding tubes such as percutaneous endoscopic gastrostomy (PEG) tubes. In patients with a protected airway, enteral nutrition has been reported to continue during invasive surgical procedures. Nonetheless, University Hospital's current SOC for holding enteral nutrition prior to undergoing surgical procedures under anesthesia is 8 hours. However, the current American Society of Anesthesiologists (ASA) guidelines do not make provision for inpatients receiving supplemental enteral nutrition. Enteral nutrition contains protein, fat, and carbohydrates, mimicking what patients would consume with a solid food meal. Balancing the need of optimized nutrition in critically ill patients with an unprotected airway against the risk of aspiration during surgical procedures brings a need for clear guidance on when to hold enteral nutrition prior to undergoing a tracheostomy procedure.
- Conditions
- Gastrostomy, Tracheostomy
- Being tested
- Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure., Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.
- Keywords
- Percutaneous Endoscopic Gastrostomy, Tracheostomy, Enteral feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.Other
Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure (tracheostomy + PEG or PEG only).
Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.Other
Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure (tracheostomy + PEG or PEG only).
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving PEG nutrition, scheduled for tracheostomy placement. | Experimental | Not described Receives: Other: Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.; Other: Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure. |
| Patients receiving naso-enteral feeding, scheduled for PEG placement. | Experimental | Not described Receives: Other: Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.; Other: Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement.
Measurement of stomach contents will be done with enteral feeding stopped at different time points prior to undergoing the surgical procedure.
Measured: 0-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start25 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GastrostomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The two groups per arm in this study are: 1. Nutrition will be stopped when the patient is called to the OR for scheduled procedure. 2. Nutrition will be stopped 2 hours before the scheduled procedure.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey Coughenour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey Coughenour, University of Missouri-Columbia
- Investigators
- Jeffrey Coughenour, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431048
- Sponsor's protocol ID
- 2101744
- Status last verified
- Oct 2026
- First submitted
- 16 May 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glanz, S. Hold the feeds … or not? Exploring intraoperative feeding. Published online 2019:2017-2019.
Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707Carmichael H, Joyce S, Smith T, Patton L, Lambert Wagner A, Wiktor AJ. Safety and efficacy of intraoperative gastric feeding during burn surgery. Burns. 2019 Aug;45(5):1089-1093. doi: 10.1016/j.burns.2018.12.009. Epub 2019 Apr 1.
PubMed 30948280Schneider JA, Lee YJ, Grubb WR, Denny J, Hunter C. Institutional practices of withholding enteral feeding from intubated patients. Crit Care Med. 2009 Jul;37(7):2299-302. doi: 10.1097/CCM.0b013e3181a007eb.
PubMed 19455023Shahmanyan D, Lawrence JC, Lollar DI, Hamill ME, Faulks ER, Collier BR, Chestovich PJ, Bower KL. Early feeding after percutaneous endoscopic gastrostomy tube placement in patients who require trauma and surgical intensive care: A retrospective cohort study. JPEN J Parenter Enteral Nutr. 2022 Jul;46(5):1160-1166. doi: 10.1002/jpen.2303. Epub 2022 Jan 27.
PubMed 34791680
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No DIET Trial: Dogmatic Interruption of Enteral nuTrition
- ClinicalTrials.gov ID
- NCT06431048
- Acronym / sponsor ID
- 2101744
- Conditions
- Gastrostomy, Tracheostomy
- Keywords
- Percutaneous Endoscopic Gastrostomy, Tracheostomy, Enteral feeding
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jeffrey CoughenourUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 May 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.
There is currently limited guidance on when to hold nutritional supplementation through for patients, who are receiving tube feeding, undergoing surgical procedures. This study aims to investigate which time would be the best to stop nutrition, if at all, before undergoing a surgical procedure.
Detailed description
The risk for malnutrition-associated complications is high for patients in the trauma- surgical-, and neurological intensive care units. Patients with persistent neurologic impairment often require nutritional supplementation through a variety of naso-enteral or surgical feeding tubes such as percutaneous endoscopic gastrostomy (PEG) tubes. In patients with a protected airway, enteral nutrition has been reported to continue during invasive surgical procedures. Nonetheless, University Hospital's current SOC for holding enteral nutrition prior to undergoing surgical procedures under anesthesia is 8 hours. However, the current American Society of Anesthesiologists (ASA) guidelines do not make provision for inpatients receiving supplemental enteral nutrition. Enteral nutrition contains protein, fat, and carbohydrates, mimicking what patients would consume with a solid food meal. Balancing the need of optimized nutrition in critically ill patients with an unprotected airway against the risk of aspiration during surgical procedures brings a need for clear guidance on when to hold enteral nutrition prior to undergoing a tracheostomy procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The two groups per arm in this study are: 1. Nutrition will be stopped when the patient is called to the OR for scheduled procedure. 2. Nutrition will be stopped 2 hours before the scheduled procedure.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving PEG nutrition, scheduled for tracheostomy placement. | Experimental | Other: Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure., Other: Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure. |
| Patients receiving naso-enteral feeding, scheduled for PEG placement. | Experimental | Other: Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure., Other: Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged >18 years.
- Patients who require a tracheostomy or PEG placement.
Key exclusion criteria (3 listed)
- Patients with gastric and/or bowel obstruction.
- Patients unable to receive enteral nutrition.
- Patients who are pregnant and/or breastfeeding.
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 |
|---|---|---|
| Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure.Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure (tracheostomy + PEG or PEG only). | Other | Patients receiving PEG nutrition, scheduled for tracheostomy placement., Patients receiving naso-enteral feeding, scheduled for PEG placement. |
| Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure.Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure (tracheostomy + PEG or PEG only). | Other | Patients receiving PEG nutrition, scheduled for tracheostomy placement., Patients receiving naso-enteral feeding, scheduled for PEG placement. |
Primary outcome
Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement.
Time frame: 0-8 hours
Measurement of stomach contents will be done with enteral feeding stopped at different time points prior to undergoing the surgical procedure.
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 22 Oct 2026.
- BackgroundGlanz, S. Hold the feeds … or not? Exploring intraoperative feeding. Published online 2019:2017-2019.
- Background: PubMed 28045707Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
- Background: PubMed 30948280Carmichael H, Joyce S, Smith T, Patton L, Lambert Wagner A, Wiktor AJ. Safety and efficacy of intraoperative gastric feeding during burn surgery. Burns. 2019 Aug;45(5):1089-1093. doi: 10.1016/j.burns.2018.12.009. Epub 2019 Apr 1.
- Background: PubMed 19455023Schneider JA, Lee YJ, Grubb WR, Denny J, Hunter C. Institutional practices of withholding enteral feeding from intubated patients. Crit Care Med. 2009 Jul;37(7):2299-302. doi: 10.1097/CCM.0b013e3181a007eb.
- Background: PubMed 34791680Shahmanyan D, Lawrence JC, Lollar DI, Hamill ME, Faulks ER, Collier BR, Chestovich PJ, Bower KL. Early feeding after percutaneous endoscopic gastrostomy tube placement in patients who require trauma and surgical intensive care: A retrospective cohort study. JPEN J Parenter Enteral Nutr. 2022 Jul;46(5):1160-1166. doi: 10.1002/jpen.2303. Epub 2022 Jan 27.
- Individual participant dataSharing planned: No
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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.
Jeffrey Coughenour, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naso-enteral nutrition will be stopped when the patient is called to the OR for scheduled procedure. and Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure. in people with Gastrostomy and Tracheostomy, run by Jeffrey Coughenour 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 2 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: enrolling by invitation, as of the sponsor's last update on 22 Oct 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring stomach contents in patients undergoing a tracheostomy and/or PEG placement. (time frame: 0-8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06431048, which also lists 5 linked publications.
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 22 Oct 2026.