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

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 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 Overview

• Status: Not yet recruiting
• Conditions: Intensive Care; Nutrition
• Intervention / Treatment: Diagnostic test: pH indication with NGPOD

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florence LECERF; Phone Number: +33140942517; Email: f.lecerf@ghpsj.fr
• Study Contact Backup: Name: Audrey IMBERT; Phone Number: +33140948589; Email: a.imbert@ghpsj.fr

Study Locations

• France
  • Le Plessis-Robinson, France, 92350
    • Hopital Marie Lannelongue
    • Principal Investigator: Audrey IMBERT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients requiring an orogastric or nasogastric tube

Diagnostic test: pH indication with NGPOD; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probe malpositioning	collection of malpositioning site	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.	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	Up to one Day
x-ray manipulators time	Evaluation of the working time of radiology manipulators	"through study completion, an average of 1 year"
Adverse events occurring during the study period		"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	Up to one Day

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: PH; naso gastric tube; oro gastric tube
• Other Study ID Numbers: 2023-A02294-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No