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

September 4, 2026 updated by: Centre Hospitalier le Mans

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 72037
        • Recruiting
        • CHU Angers
        • Contact:
        • Principal Investigator:
          • Carole HAUBERTIN
      • Cholet, France, 49325
        • Recruiting
        • Ch Cholet
        • Contact:
        • Principal Investigator:
          • Laetitia MENARD
      • Grenoble, France, 38043
        • Recruiting
        • Chu Grenoble
        • Contact:
        • Principal Investigator:
          • Prescillia GAMON
      • La Roche-sur-Yon, France, 85925
        • Recruiting
        • CHD Vendée
        • Contact:
        • Principal Investigator:
          • Cécile ROUSSEAU
      • Le Mans, France, 72000
        • Recruiting
        • Centre Hospitalier du Mans
        • Contact:
        • Principal Investigator:
          • Josselin SALETES
      • Marseille, France, 13015
        • Recruiting
        • APHM - Hôpital Nord
        • Contact:
        • Principal Investigator:
          • Sabine VALERA
      • Nantes, France, 44093
        • Recruiting
        • CHU Nantes
        • Contact:
        • Principal Investigator:
          • Carole OUISSE
      • Orléans, France, 45067
        • Recruiting
        • CHRU Orléans
        • Principal Investigator:
          • Lucie MULLER
        • Contact:
      • Paris, France, 75012
        • Recruiting
        • APHP - Hôpital Saint-Antoine
        • Contact:
        • Principal Investigator:
          • Johanne RATINAUD
      • Poitiers, France, 86021
        • Recruiting
        • CHU Poitiers
        • Principal Investigator:
          • Célina MORAND
        • Contact:
      • Périgueux, France, 24019
        • Recruiting
        • CH Périgueux
        • Contact:
        • Principal Investigator:
          • Aurélie LEJEUNE
      • Rennes, France, 35000
        • Recruiting
        • Chu Rennes
        • Contact:
        • Principal Investigator:
          • Nathanael MANGEARD
      • Saint-Nazaire, France, 44600
        • Recruiting
        • CH Saint-Nazaire
        • Contact:
        • Principal Investigator:
          • Antoine GARIN
      • Strasbourg, France, 67098
        • Recruiting
        • CHRU Strasbourg - Hôpital de Hautepierre
        • Contact:
        • Principal Investigator:
          • Céline PICART
      • Toulon, France, 83056
        • Recruiting
        • CHIC Toulon - La Seyne sur Mer
        • Contact:
        • Principal Investigator:
          • Pierre-Yves ARNAUD
      • Tours, France, 37044
        • Recruiting
        • CHRU Tours - Hôpital Bretonneau
        • Contact:
        • Principal Investigator:
          • Grégory PARIS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nasogastric
nasogastric tube in period 1 and orogastric tube in period 2
Other: nasogastric tube and orogastric tube
nasogastric tube in period 1 and orogastric tube in period 2
Experimental: Orogastric
orogastric tube in period 1 and nasogastric tube in period 2
Other: orogastric tube and nasogastric tube
orogastric tube in period 1 and nasogastric tube in period 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts before successful insertion or reinsertion confirmed by control according to service protocol
Time Frame: At gastric tube insertion or reinsertion procedure
At gastric tube insertion or reinsertion procedure
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.
From Day 0 to Day 28
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.
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
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.
From Day 0 to Day 28
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.
From Day 0 to Day 28
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.).
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
From Day 0 to Day 28
Morbidity
Time Frame: From admission to discharge from the intensive care unit
Duration of artificial ventilation and length of stay in intensive care unit.
From admission to discharge from the intensive care unit
Mortality
Time Frame: From Day 0 to Day 28
Mortality in intensive care unit and Mortality at D28.
From Day 0 to Day 28
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.
From Day 0 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier le Mans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2024

Primary Completion (Estimated)

April 7, 2027

Study Completion (Estimated)

April 7, 2027

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHM-2022/S03/05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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