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NCT Number: NCT05915663

Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia

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.

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Key information

Conditions

Intubated Patient Requiring a Gastric Tube Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasogastric tube and orogastric tube

Other

nasogastric tube in period 1 and orogastric tube in period 2

orogastric tube and nasogastric tube

Other

orogastric tube in period 1 and nasogastric tube in period 2

Primary outcomes

  1. Compare impact of insertion site of gastric tube on the incidence of ventilator associated pneumoniae

    Time frame: Day 28

    The impact is measured by the number of ventilator associated peumonia

Secondary outcomes

  1. Number of attempts before successful insertion or reinsertion confirmed by control according to service protocol

    Time frame: At gastric tube insertion or reinsertion procedure

  2. Pain monitoring (pain scale) during insertion or reinsertion of the gastric tube

    Time frame: 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.

  3. Pain monitoring (pain scale) during daily repair of the fixation system of the gastric tube

    Time frame: 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.

  4. Absence or presence of skin lesions qualified by location and according to the NPUAP classification of pressure ulcer stages

    Time frame: 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.

  5. Absence or presence and qualification of nasal discharge

    Time frame: From Day 0 to Day 28

    Qualification according to the following four criteria:

    • No flow.
    • Serous discharge.
    • Bloody discharge.
    • Purulent discharge.

  6. Presence of bleeding during gastric tube insertion or reinsertion

    Time frame: 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.).

  7. Presence of diagnosed and treated ulcer and/or diagnosed and treated esophagitis

    Time frame: From Day 0 to Day 28

  8. Morbidity

    Time frame: From admission to discharge from the intensive care unit

    Duration of artificial ventilation and length of stay in intensive care unit.

  9. Mortality

    Time frame: From Day 0 to Day 28

    Mortality in intensive care unit and Mortality at D28.

  10. Number and type of adverse events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle JADEAU

CONTACT

[email protected]

+33244710781

Josselin SALETES

CONTACT

[email protected]

+33 2 55 46 34 55

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Official study title

Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia and Other Complications in the Intensive Care Unit

Acronym: SONG

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2023
Registry last updated
Sep 10, 2026

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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