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

NCT ID: NCT05915663

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubated Patient Requiring a Gastric Tube

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised cluster and cross-over study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nasogastric

nasogastric tube in period 1 and orogastric tube in period 2

Group Type EXPERIMENTAL

nasogastric tube and orogastric tube

Intervention Type OTHER

nasogastric tube in period 1 and orogastric tube in period 2

Orogastric

orogastric tube in period 1 and nasogastric tube in period 2

Group Type EXPERIMENTAL

orogastric tube and nasogastric tube

Intervention Type OTHER

orogastric tube in period 1 and nasogastric tube in period 2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nasogastric tube and orogastric tube

nasogastric tube in period 1 and orogastric tube in period 2

Intervention Type OTHER

orogastric tube and nasogastric tube

orogastric tube in period 1 and nasogastric tube in period 2

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier le Mans

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Du Mans

Le Mans, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christelle JADEAU

Role: CONTACT

+33244710781

Josselin SALETES

Role: CONTACT

+33 2 55 46 34 55

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christelle JADEAU

Role: primary

+33244710781

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40921641 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHM-2022/S03/05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Facilitation of NGT Insertion
NCT02764632 COMPLETED NA