Intubated Patient Requiring a Gastric Tube
Conditions
Keywords
orogastric tube, nasogastric tube, Ventilator Associated Pneumonia
Brief summary
In intensive care, many gastric tubes are inserted on a regular basis. There are different practices in terms of the location of the gastric tube. In some cases, the tube is inserted through the nose and in others, it is inserted through the mouth. In the literature and in practice, these gastric tubes create discomfort and complications that have an impact not only on the patient, but also on the treatments and the length of the patient's stay in hospital. Nosocomial Ventilator Associated Pneumonia is the most serious common complication for patients intubated with a gastric tube. It is possible that placement site may have an impact on the risk of developing Ventilator Associated Pneumonia, particularly by increasing the risk of bacterial pullulation opposite the sinuses when the tube is placed via the nasal route. Investigator hypothesises that placing the gastric tube orally will reduce the rate of ventilator-associated pneumonia compared with the nasal route in mechanically ventilated intensive care patients.
Interventions
OTHERnasogastric tube and orogastric tube
nasogastric tube in period 1 and orogastric tube in period 2
OTHERorogastric tube and nasogastric tube
orogastric tube in period 1 and nasogastric tube in period 2
Sponsors
Centre Hospitalier le Mans
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomised cluster and cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient in intensive care, intubated, ventilated * Adult * Requiring a gastric tube * With an expected duration of mechanical ventilation of more than 48 hours * Affiliated to social security * Patient or relative consent or, failing that, emergency inclusion of the patient
Exclusion criteria
* Pregnant, breast-feeding or parturient women * Patients under legal protection: curatorship and guardianship * Contraindication to placing a gastric tube through the nose or mouth * Patients who already have a gastric tube when they enter the service * Patient intubated for more than 24 hours * Patient intubated via the nasotracheal route
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare impact of insertion site of gastric tube on the incidence of ventilator associated pneumoniae | Day 28 | The impact is measured by the number of ventilator associated peumonia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts before successful insertion or reinsertion confirmed by control according to service protocol | At gastric tube insertion or reinsertion procedure | — |
| Pain monitoring (pain scale) during insertion or reinsertion of the gastric tube | From Day 0 to Day 28 | Assessed based on the patient's neurological status : * The Visual Analog Score for pain for vigilant patients (Glasgow score greater than or equal to 12). * The algo plus scale for patients with a Glasgow score below 12 or who are unable to rate their pain. * The Behavioral Pain Scale BPS if the patient is sedated. * If the patient is curarized, there will be no pain monitoring. |
| Pain monitoring (pain scale) during daily repair of the fixation system of the gastric tube | From Day 0 to Day 28 | Assessed based on the patient's neurological status : * The Visual Analog Score for pain for vigilant patients (Glasgow score greater than or equal to 12). * The algo plus scale for patients with a Glasgow score below 12 or who are unable to rate their pain. * The Behavioral Pain Scale BPS if the patient is sedated. * If the patient is curarized, there will be no pain monitoring. |
| Absence or presence of skin lesions qualified by location and according to the NPUAP classification of pressure ulcer stages | From Day 0 to Day 28 | NPUAP classification of pressure ulcer stages : * Stage 1: erythema that does not disappear with pressure. * Stage 2: de-epidermalization (Epidermal loss). * Stade 3: necrosis. * Stage 4: Deep-tissue involvement. |
| Absence or presence and qualification of nasal discharge | From Day 0 to Day 28 | Qualification according to the following four criteria: * No flow. * Serous discharge. * Bloody discharge. * Purulent discharge. |
| Presence of bleeding during gastric tube insertion or reinsertion | At gastric tube insertion or reinsertion procedure | Presence of bleeding during insertion or reinsertion, requiring a change in the course of treatment (bloody buccal aspirations - or IOT-related trauma -compression, packing, change of insertion site, endoscopic haemostasis, Blakemore probe insertion, therapeutic modification, etc.). |
| Presence of diagnosed and treated ulcer and/or diagnosed and treated esophagitis | From Day 0 to Day 28 | — |
| Morbidity | From admission to discharge from the intensive care unit | Duration of artificial ventilation and length of stay in intensive care unit. |
| Mortality | From Day 0 to Day 28 | Mortality in intensive care unit and Mortality at D28. |
| Number and type of adverse events | From Day 0 to Day 28 | Nature of adverse events can be : * Ablation * Mobilization of probe * Plicature of probe * Probe obstruction * Coiling of probe * False path. |
Countries
France
Contacts
CONTACTChristelle JADEAU
CONTACTJosselin SALETES
Outcome results
None listed