An interventional study of nasogastric tube and orogastric tube and orogastric tube and nasogastric tube in Intubated Patient Requiring a Gastric Tube, sponsored by Centre Hospitalier le Mans. Recruiting at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Other
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.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
nasogastric tube in period 1 and orogastric tube in period 2
Other: nasogastric tube and orogastric tube
orogastric tube in period 1 and nasogastric tube in period 2
Other: orogastric tube and nasogastric tube
nasogastric tube in period 1 and orogastric tube in period 2
orogastric tube in period 1 and nasogastric tube in period 2
Compare impact of insertion site of gastric tube on the incidence of ventilator associated pneumoniae
The impact is measured by the number of ventilator associated peumonia
Time frame: Day 28
Number of attempts before successful insertion or reinsertion confirmed by control according to service protocol
Time frame: At gastric tube insertion or reinsertion procedure
Pain monitoring (pain scale) during insertion or reinsertion of the gastric tube
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.
Time frame: From Day 0 to Day 28
Pain monitoring (pain scale) during daily repair of the fixation system of the gastric tube
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.
Time frame: From Day 0 to Day 28
Absence or presence of skin lesions qualified by location and according to the NPUAP classification of pressure ulcer stages
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.
Time frame: From Day 0 to Day 28
Absence or presence and qualification of nasal discharge
Qualification according to the following four criteria: * No flow. * Serous discharge. * Bloody discharge. * Purulent discharge.
Time frame: From Day 0 to Day 28
Presence of bleeding during gastric tube insertion or reinsertion
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.).
Time frame: At gastric tube insertion or reinsertion procedure
Presence of diagnosed and treated ulcer and/or diagnosed and treated esophagitis
Time frame: From Day 0 to Day 28
Morbidity
Duration of artificial ventilation and length of stay in intensive care unit.
Time frame: From admission to discharge from the intensive care unit
Mortality
Mortality in intensive care unit and Mortality at D28.
Time frame: From Day 0 to Day 28
Number and type of adverse events
Nature of adverse events can be : * Ablation * Mobilization of probe * Plicature of probe * Probe obstruction * Coiling of probe * False path.
Time frame: From Day 0 to Day 28
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pneumonia, Ventilator-Associated →
Centre Hospitalier le Mans