NCT05915663

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Oct 2024Mar 2027

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

2.4 years

First QC Date

June 14, 2023

Last Update Submit

August 27, 2024

Conditions

Intubated Patient Requiring a Gastric Tube

Keywords

orogastric tubenasogastric tubeVentilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 28

Study Arms (2)

Nasogastric

EXPERIMENTAL

nasogastric tube in period 1 and orogastric tube in period 2

Other: nasogastric tube and orogastric tube

Orogastric

EXPERIMENTAL

orogastric tube in period 1 and nasogastric tube in period 2

Other: orogastric tube and nasogastric tube

Interventions

nasogastric tube and orogastric tubeOTHER

nasogastric tube in period 1 and orogastric tube in period 2

Nasogastric
orogastric tube and nasogastric tubeOTHER

orogastric tube in period 1 and nasogastric tube in period 2

Orogastric

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

Location

Related Publications (1)

  • 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.

    PMID: 40921641DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Central Study Contacts

Christelle JADEAU

CONTACT

+33244710781cjadeau@ch-lemans.fr

Josselin SALETES

CONTACT

+33 2 55 46 34 55jsaletes@ch-lemans.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomised cluster and cross-over study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

October 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 29, 2024

Record last verified: 2024-08

Locations

FR(1)