Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care.

NCT06316986 | Completed

• 1 other identifier: 2023-A02294-41
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intensive Care; Nutrition

Keywords

naso gastric tube; oro gastric tube; PH

Outcome Measures

Primary Outcomes (1)

• Ability of the NGPOD device to detect correct positioning of the gastric tube.

  Comparison of NGPOD and chest X-ray results.

  Up to one Day

Secondary Outcomes (6)

• Probe malpositioning

  Up to one Day

• Time to validate correct positioning of gastric tube

  Up to one Day

• Evaluation of the "simplicity" of the procedures for using and interpreting the NGPOD system

  Up to one Day

• x-ray manipulators time

  "through study completion, an average of 1 year"

• Adverse events occurring during the study period

  "through study completion, an average of 1 year"

Study Arms (1)

Patients requiring an orogastric or nasogastric tube

EXPERIMENTAL

Diagnostic Test: pH indication with NGPOD

Interventions

pH indication with NGPOD DIAGNOSTIC_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.

Patients requiring an orogastric or nasogastric tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Related Publications (3)

• 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.

  PMID: 30348463 BACKGROUND

• Metheny 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.

  PMID: 17268247 BACKGROUND

• Metheny 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.

  PMID: 30665700 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: March 19, 2024
• Study Start: May 7, 2024
• Primary Completion: December 27, 2024
• Study Completion: April 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

FR (1)