Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350, France
NCT Number: NCT06316986
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Le Plessis-Robinson, 92350, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to one Day
Comparison of NGPOD and chest X-ray results.
Time frame: Up to one Day
collection of malpositioning site
Time frame: Up to one Day
This time will be calculated as the difference between the following times:
Time frame: Up to one Day
Scale from 0 to 10- 0 for easy and 10 for very difficult
Time frame: "through study completion, an average of 1 year"
Evaluation of the working time of radiology manipulators
Time frame: "through study completion, an average of 1 year"
Time frame: Up to one Day
Fondation Hôpital Saint-Joseph
Other
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
Acronym: NGPOD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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