Back to resultsImpact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia (SONG)
Primary Purpose
Intubated Patient Requiring a Gastric Tube
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nasogastric tube and orogastric tube
orogastric tube and nasogastric tube
Sponsored by
About this trial
This is an interventional other trial for Intubated Patient Requiring a Gastric Tube focused on measuring orogastric tube, nasogastric tube, Ventilator Associated Pneumonia
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Du Mans
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
nasogatric tube in period 1 and orogastric tube in period 2
orogastric tube in period 1 and nasogatric tube in period 2
Outcomes
Primary Outcome Measures
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 peumoniae
Secondary Outcome Measures
Full Information
NCT ID
NCT05915663
First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Centre Hospitalier le Mans
1. Study Identification
Unique Protocol Identification Number
NCT05915663
Brief Title
Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia
Acronym
SONG
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 pululation 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubated Patient Requiring a Gastric Tube
Keywords
orogastric tube, nasogastric tube, Ventilator Associated Pneumonia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised cluster and cross-over study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
nasogatric tube in period 1 and orogastric tube in period 2
Arm Title
Arm B
Arm Type
Experimental
Arm Description
orogastric tube in period 1 and nasogatric tube in period 2
Intervention Type
Other
Intervention Name(s)
nasogastric tube and orogastric tube
Intervention Description
nasogastric tube in period 1 and orogastric tube in period 2
Intervention Type
Other
Intervention Name(s)
orogastric tube and nasogastric tube
Intervention Description
orogastric tube in period 1 and nasogastric tube in period 2
Primary Outcome Measure Information:
Title
Compare impact of insertion site of gastric tube on the incidence of ventilator associated pneumoniae
Description
The impact is measured by the number of ventilator associated peumoniae
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle JADEAU
Phone
+33244710781
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Josselin SALETES
Phone
+33 2 55 46 34 55
Email
jsaletes@ch-lemans.fr
Facility Information:
Facility Name
Centre Hospitalier Du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle JADEAU
Phone
+33244710781
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Josselin SALETES
12. IPD Sharing Statement
Learn more about this trial
Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia
We'll reach out to this number within 24 hrs