Intubated Patient Requiring a Gastric TubeSONGNCT05915663
Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia
A study testing nasogastric tube and orogastric tube and orogastric tube and nasogastric tube in people with Intubated Patient Requiring a Gastric Tube, run by Centre Hospitalier le Mans at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubated Patient Requiring a Gastric Tube
- What is being tested?
- nasogastric tube and orogastric tube and orogastric tube and nasogastric tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 16 sitesFrance
- Study dates
- 7 Nov 2024to 7 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
France16 sites, 16 recruiting
- Recruiting
CHU Angers
Angers, 72037
Carole HAUBERTIN, +336 65 80 68 98, carole.haubertin@chu-angers.fr
Carole HAUBERTIN
- Recruiting
CH Cholet
Cholet, 49325
Laetitia MENARD, +332 41 49 69 85, laetita.menard@ch-cholet.fr
Laetitia MENARD
- Recruiting
CHU Grenoble
Grenoble, 38043
Prescillia GAMON, +334 76 76 71 09, pgamon@chu-grenoble.fr
Prescillia GAMON
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85925
Cécile ROUSSEAU, +332 51 44 60 26, cecile.rousseau@chd-vendee.fr
Cécile ROUSSEAU
- Recruiting
Centre Hospitalier Du Mans
Le Mans, 72000
Christelle JADEAU, +33244710781, cjadeau@ch-lemans.fr
Josselin SALETES
- Recruiting
APHM - Hôpital Nord
Marseille, 13015
Sabine VALERA, +334 91 96 58 45, sabine.valera@aphm.fr
Sabine VALERA
- Recruiting
CHU Nantes
Nantes, 44093
Carole OUISSE, +332 40 08 73 65, carole.ouisse@chu-nantes.fr
Carole OUISSE
- Recruiting
CHRU Orléans
Orléans, 45067
Lucie MULLER, +332 38 22 99 35, lucie.muller@chr-orleans.fr
Lucie MULLER
- Recruiting
APHP - Hôpital Saint-Antoine
Paris, 75012
Johanne RATINAUD, +331 49 28 20 00, johanne.ratinaud@aphp.fr
Johanne RATINAUD
- Recruiting
CH Périgueux
Périgueux, 24019
Aurélie LEJEUNE, +335 53 45 26 57, lililanamohea@gmail.com
Aurélie LEJEUNE
- Recruiting
CHU Poitiers
Poitiers, 86021
Célina MORAND, +335 49 44 60 64, Celina.MORAND@chu-poitiers.fr
Célina MORAND
- Recruiting
CHU Rennes
Rennes, 35000
Nathanaël MANGEARD, +332 99 28 98 89, Nathanael.MANGEARD@chu-rennes.fr
Nathanael MANGEARD
- Recruiting
CH Saint-Nazaire
Saint-Nazaire, 44600
Antoine GARIN, +332 72 27 84 03, garin.antoine44@gmail.com
Antoine GARIN
- Recruiting
CHRU Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
Céline PICART, +333 88 12 79 14, celine.picart@chru-strasbourg.fr
Céline PICART
- Recruiting
CHIC Toulon - La Seyne sur Mer
Toulon, 83056
Pierre-Yves ARNAUD, +334 94 14 52 23, pyarnaud.p@gmail.com
Pierre-Yves ARNAUD
- Recruiting
CHRU Tours - Hôpital Bretonneau
Tours, 37044
Grégory PARIS, +332 47 47 38 55, G.PARIS@chu-tours.fr
Grégory PARIS
About this study
Official 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
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.
Read more
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.
- Being tested
- nasogastric tube and orogastric tube, orogastric tube and nasogastric tube
- Keywords
- orogastric tube, nasogastric tube, Ventilator Associated Pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasogastric tube and orogastric tubeOther
nasogastric tube in period 1 and orogastric tube in period 2
orogastric tube and nasogastric tubeOther
orogastric tube in period 1 and nasogastric tube in period 2
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric | Experimental | nasogastric tube in period 1 and orogastric tube in period 2 Receives: Other: nasogastric tube and orogastric tube |
| Orogastric | Experimental | orogastric tube in period 1 and nasogastric tube in period 2 Receives: Other: orogastric tube and nasogastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 28
Secondary outcomes (10)
Number of attempts before successful insertion or reinsertion confirmed by control according to service protocol
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.).
Measured: At gastric tube insertion or reinsertion procedure
Presence of diagnosed and treated ulcer and/or diagnosed and treated esophagitis
Measured: From Day 0 to Day 28
Morbidity
Duration of artificial ventilation and length of stay in intensive care unit.
Measured: From admission to discharge from the intensive care unit
Mortality
Mortality in intensive care unit and Mortality at D28.
Measured: 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.
Measured: From Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start7 Nov 2024
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubated Patient Requiring a Gastric TubeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised cluster and cross-over study
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915663
- Sponsor's protocol ID
- CHM-2022/S03/05
- Acronym
- SONG
- Status last verified
- Sep 2026
- First submitted
- 14 Jun 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saletes J, Guitton C, Valleroy J, Guillarme S, Haubertin C, Paris G, Muller L, Rousseau C, Gamon P, L'Hotellier S, Forel JM, Roussel C, Garin A, Morand C, Maury E, Mangeard N, Menard L, Arnaud PY, Lejeune A, Rouanet E, Callahan JC. Effect of nasogastric versus orogastric tube placement on ventilator-associated pneumonia incidence in critically ill patients: a study protocol for a cluster randomised crossover trial in 16 intensive care units in France (SONG trial). BMJ Open. 2025 Sep 8;15(9):e099840. doi: 10.1136/bmjopen-2025-099840.
PubMed 40921641
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05915663
- Acronym / sponsor ID
- SONG / CHM-2022/S03/05
- Keywords
- orogastric tube, nasogastric tube, Ventilator Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised cluster and cross-over study
| Arm | Type | Receives |
|---|---|---|
| Nasogastric | Experimental | Other: nasogastric tube and orogastric tubenasogastric tube in period 1 and orogastric tube in period 2 |
| Orogastric | Experimental | Other: orogastric tube and nasogastric tubeorogastric tube in period 1 and nasogastric tube in period 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasogastric tube and orogastric tubenasogastric tube in period 1 and orogastric tube in period 2 | Other | Nasogastric |
| orogastric tube and nasogastric tubeorogastric tube in period 1 and nasogastric tube in period 2 | Other | Orogastric |
Primary outcome
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
10 secondary outcomes
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
Time frame: 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
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
Absence or presence and qualification of nasal discharge
Time frame: 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 diagnosed and treated ulcer and/or diagnosed and treated esophagitis
Time frame: From Day 0 to Day 28
Morbidity
Time frame: From admission to discharge from the intensive care unit
Mortality
Time frame: From Day 0 to Day 28
Number and type of adverse events
Time frame: From Day 0 to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 40921641Saletes J, Guitton C, Valleroy J, Guillarme S, Haubertin C, Paris G, Muller L, Rousseau C, Gamon P, L'Hotellier S, Forel JM, Roussel C, Garin A, Morand C, Maury E, Mangeard N, Menard L, Arnaud PY, Lejeune A, Rouanet E, Callahan JC. Effect of nasogastric versus orogastric tube placement on ventilator-associated pneumonia incidence in critically ill patients: a study protocol for a cluster randomised crossover trial in 16 intensive care units in France (SONG trial). BMJ Open. 2025 Sep 8;15(9):e099840. doi: 10.1136/bmjopen-2025-099840.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasogastric tube and orogastric tube and orogastric tube and nasogastric tube in people with Intubated Patient Requiring a Gastric Tube, run by Centre Hospitalier le Mans at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle JADEAU (+33244710781, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare impact of insertion site of gastric tube on the incidence of ventilator associated pneumoniae (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05915663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.