Intensive Care, Nutrition
Conditions
Keywords
naso gastric tube, oro gastric tube, PH
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.
Interventions
DIAGNOSTIC_TESTpH 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.
Sponsors
Fondation Hôpital Saint-Joseph
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of the NGPOD device to detect correct positioning of the gastric tube. | Up to one Day | Comparison of NGPOD and chest X-ray results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to validate correct positioning of gastric tube | Up to one Day | 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. |
| Evaluation of the simplicity of the procedures for using and interpreting the NGPOD system | Up to one Day | Scale from 0 to 10- 0 for easy and 10 for very difficult |
| Probe malpositioning | Up to one Day | collection of malpositioning site |
| 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 | Up to one Day | * patients treated with proton pump inhibitors * patients who received nutrition within 6 hours prior to tube insertion |
| x-ray manipulators time | through study completion, an average of 1 year | Evaluation of the working time of radiology manipulators |
Countries
France
Outcome results
None listed