Intensive CareNGPODNCT06316986
Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care.
A study testing pH indication with NGPOD in people with Intensive Care and Nutrition, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
In the Intensive Care Unit (ICU), scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care, Nutrition
- What is being tested?
- pH indication with NGPOD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient hospitalized in intensive care
- Patients aged 18 or over with no upper age limit
- Patients admitted to intensive care with a nasogastric or orogastric tube placed in the operating room (not controlled by radiography) or for whom the placement of a gastric tube in intensive care is indicated.
- Consent to research participation
Who cannot join
- Patients undergoing limitation and discontinuation of active therapies
- Patients with contraindications to blind gastric tube placement (recent esophageal or gastric surgery, ENT lesions, uncontrolled upper GI bleeding, esophageal or gastric cancer)
- Patients under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care : Prospective Monocentric Clinical Investigation
In the Intensive Care Unit (ICU), scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. In patients who are sedated, have swallowing problems or cannot ensure adequate caloric intake, it is essential to insert a feeding tube, usually a nasogastric or orogastric tube for the first few weeks.
Placement of a naso- or oro-gastric tube in the intensive care unit is a frequent procedure, and considered to be straightforward. It is usually performed blindly, at the patient's bedside, by a nurse or doctor, according to a departmental protocol or the recommendations of learned societies.
Read more
Nevertheless, a number of complications have been reported with naso- or oro-gastric tubes, linked in particular to a route outside the digestive tract : malpositioning/coiling of the tube, epistaxis, sinusitis. The most frequent and potentially severe complications are malpositions in the tracheobronchial tree.
Radiographic control is currently considered in France and by certain learned societies to be the reference method for verifying correct positioning of the probe in the stomach (at the prepyloric antral level). However, thoracic radiography has a number of drawbacks : In intensive care risk of accidental displacement of other medical devices,irradiation, difficulty of interpretation, delay in obtaining the image, time-consuming work for qualified personnel.
An alternative technique using the NGPOD device is proposed as a method of checking the correct positioning of the probe in the stomach. This system enables immediate, rapid (15 seconds), simple and automatic testing at the patient's bedside. The device provides a visual indication of the pH detected at the tip of the gastric tube. The test result is given in binary form: Yes (green signal, probe in stomach) / No (red signal, probe incorrectly positioned).
Study hypothesis and prospects: To make an initial estimate of the sensitivity and specificity of the NGPOD system for checking the positioning of the naso- or oro-gastric tube in the stomach, compared with the recognized gold standard, the chest X-ray.
- Conditions
- Intensive Care, Nutrition
- Being tested
- pH indication with NGPOD
- Keywords
- naso gastric tube, oro gastric tube, PH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pH indication with NGPODDiagnostic test
The NGPOD sensor is inserted into the naso- or oro-gastric tube, then reconnected to the NGPOD handheld device, and the pH measurement is taken within 15 seconds.
When the 15 seconds have elapsed, the pH button is pressed. If the green LED lights up and the pH indicates a value < 5.5, the sensor tip is in a pH environment associated with the stomach.
If the red LED lights up, the sensor tip is in a pH environment NOT associated with the stomach.
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring an orogastric or nasogastric tube | Experimental | Not described Receives: Diagnostic Test: pH indication with NGPOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the NGPOD device to detect correct positioning of the gastric tube.
Comparison of NGPOD and chest X-ray results.
Measured: Up to one Day
Secondary outcomes (6)
Probe malpositioning
collection of malpositioning site
Measured: Up to one Day
Time to validate correct positioning of gastric tube
This time will be calculated as the difference between the following times:
- T0: time when the SNG is installed and checked by auscultation.
- TNGPOD: time when SNG positioning is estimated by the NGPOD system.
- TRT: time when the positioning of the SNG is estimated in place in the stomach on the chest X-ray, by a doctor.
- TRTDEF: time when the positioning of the SNG is estimated in place by the doctor on the 2nd x-ray, in the event that the probe is not visualized on the 1st x-ray. In the event that the X-ray does not allow the gastric tube to be visualized, the technical parameters of the X-ray and/or opacification of the tube will be modified, and a new X-ray will be taken and interpreted.
Measured: Up to one Day
Evaluation of the "simplicity" of the procedures for using and interpreting the NGPOD system
Scale from 0 to 10- 0 for easy and 10 for very difficult
Measured: Up to one Day
x-ray manipulators time
Evaluation of the working time of radiology manipulators
Measured: "through study completion, an average of 1 year"
Adverse events occurring during the study period
Measured: "through study completion, an average of 1 year"
Ability of the NGPOD device to detect correct gastric tube positioning in a subgroup of patients
- patients treated with proton pump inhibitors
- patients who received nutrition within 6 hours prior to tube insertion
Measured: Up to one Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start7 May 2024
- Primary completion27 Dec 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intensive CareStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316986
- Sponsor's protocol ID
- 2023-A02294-41
- Acronym
- NGPOD
- Status last verified
- Aug 2025
- First submitted
- 12 Jan 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
PubMed 30348463Metheny NA, Meert KL, Clouse RE. Complications related to feeding tube placement. Curr Opin Gastroenterol. 2007 Mar;23(2):178-82. doi: 10.1097/MOG.0b013e3280287a0f.
PubMed 17268247Metheny NA, Krieger MM, Healey F, Meert KL. A review of guidelines to distinguish between gastric and pulmonary placement of nasogastric tubes. Heart Lung. 2019 May-Jun;48(3):226-235. doi: 10.1016/j.hrtlng.2019.01.003. Epub 2019 Jan 18.
PubMed 30665700
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care : Prospective Monocentric Clinical Investigation
- ClinicalTrials.gov ID
- NCT06316986
- Acronym / sponsor ID
- NGPOD / 2023-A02294-41
- Conditions
- Intensive Care, Nutrition
- Keywords
- naso gastric tube, oro gastric tube, PH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 19 Mar 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.
In the Intensive Care Unit (ICU), scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. In patients who are sedated, have swallowing problems or cannot ensure adequate caloric intake, it is essential to insert a feeding tube, usually a nasogastric or orogastric tube for the first few weeks.
Placement of a naso- or oro-gastric tube in the intensive care unit is a frequent procedure, and considered to be straightforward. It is usually performed blindly, at the patient's bedside, by a nurse or doctor, according to a departmental protocol or the recommendations of learned societies.
Nevertheless, a number of complications have been reported with naso- or oro-gastric tubes, linked in particular to a route outside the digestive tract : malpositioning/coiling of the tube, epistaxis, sinusitis. The most frequent and potentially severe complications are malpositions in the tracheobronchial tree.
Radiographic control is currently considered in France and by certain learned societies to be the reference method for verifying correct positioning of the probe in the stomach (at the prepyloric antral level). However, thoracic radiography has a number of drawbacks : In intensive care risk of accidental displacement of other medical devices,irradiation, difficulty of interpretation, delay in obtaining the image, time-consuming work for qualified personnel.
An alternative technique using the NGPOD device is proposed as a method of checking the correct positioning of the probe in the stomach. This system enables immediate, rapid (15 seconds), simple and automatic testing at the patient's bedside. The device provides a visual indication of the pH detected at the tip of the gastric tube. The test result is given in binary form: Yes (green signal, probe in stomach) / No (red signal, probe incorrectly positioned).
Study hypothesis and prospects: To make an initial estimate of the sensitivity and specificity of the NGPOD system for checking the positioning of the naso- or oro-gastric tube in the stomach, compared with the recognized gold standard, the chest X-ray.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring an orogastric or nasogastric tube | Experimental | Diagnostic Test: pH indication with NGPOD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient hospitalized in intensive care
- Patients aged 18 or over with no upper age limit
- Patients admitted to intensive care with a nasogastric or orogastric tube placed in the operating room (not controlled by radiography) or for whom the placement of a gastric tube in intensive care is indicated.
- Consent to research participation
Key exclusion criteria (5 listed)
- Patients undergoing limitation and discontinuation of active therapies
- Patients with contraindications to blind gastric tube placement (recent esophageal or gastric surgery, ENT lesions, uncontrolled upper GI bleeding, esophageal or gastric cancer)
- Patients under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
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 |
|---|---|---|
| pH indication with NGPODThe NGPOD sensor is inserted into the naso- or oro-gastric tube, then reconnected to the NGPOD handheld device, and the pH measurement is taken within 15 seconds. When the 15 seconds have elapsed, the pH button is pressed. If the green LED lights up and the pH indicates a value < 5.5, the sensor tip is in a pH environment associated with the stomach. If the red LED lights up, the sensor tip is in a pH environment NOT associated with the stomach. | Diagnostic test | Patients requiring an orogastric or nasogastric tube |
Primary outcome
Ability of the NGPOD device to detect correct positioning of the gastric tube.
Time frame: Up to one Day
Comparison of NGPOD and chest X-ray results.
6 secondary outcomes
Probe malpositioning
Time frame: Up to one Day
Time to validate correct positioning of gastric tube
Time frame: Up to one Day
Evaluation of the "simplicity" of the procedures for using and interpreting the NGPOD system
Time frame: Up to one Day
x-ray manipulators time
Time frame: "through study completion, an average of 1 year"
Adverse events occurring during the study period
Time frame: "through study completion, an average of 1 year"
Ability of the NGPOD device to detect correct gastric tube positioning in a subgroup of patients
Time frame: Up to one Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 30348463Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
- Background: PubMed 17268247Metheny NA, Meert KL, Clouse RE. Complications related to feeding tube placement. Curr Opin Gastroenterol. 2007 Mar;23(2):178-82. doi: 10.1097/MOG.0b013e3280287a0f.
- Background: PubMed 30665700Metheny NA, Krieger MM, Healey F, Meert KL. A review of guidelines to distinguish between gastric and pulmonary placement of nasogastric tubes. Heart Lung. 2019 May-Jun;48(3):226-235. doi: 10.1016/j.hrtlng.2019.01.003. Epub 2019 Jan 18.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pH indication with NGPOD in people with Intensive Care and Nutrition, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 22 Aug 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ability of the NGPOD device to detect correct positioning of the gastric tube. (time frame: Up to one Day). 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 NCT06316986, which also lists 3 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 Aug 2025.