Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316986
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-01-12
Brief Title:
Performance of the NGPOD Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NGPOD
Brief Summary:
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 patients 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 malpositioningcoiling 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 devicesirradiation 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 patients 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
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 patients 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 malpositioningcoiling 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 devicesirradiation 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None