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

Sponsor

Centre Hospitalier le Mans (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05915663

Collaborator

(none)

2,400

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intubated Patient Requiring a Gastric Tube	Other: nasogastric tube and orogastric tube Other: orogastric tube and nasogastric tube	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2400 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomised cluster and cross-over studyRandomised cluster and cross-over study

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A nasogatric 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: Arm B orogastric tube in period 1 and nasogatric tube in period 2	Other: orogastric tube and nasogastric tube orogastric tube in period 1 and nasogastric tube in period 2

Arm

Intervention/Treatment

Experimental: Arm A

nasogatric 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: Arm B

orogastric tube in period 1 and nasogatric tube in period 2

Other: orogastric tube and nasogastric tube

orogastric tube in period 1 and nasogastric tube in period 2

Outcome Measures

Primary Outcome Measures

Compare impact of insertion site of gastric tube on the incidence of ventilator associated pneumoniae [Day 28]
The impact is measured by the number of ventilator associated peumoniae

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Du Mans	Le Mans		France	72000

Sponsors and Collaborators

Centre Hospitalier le Mans

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier le Mans

ClinicalTrials.gov Identifier:

NCT05915663

Other Study ID Numbers:

CHM-2022/S03/05

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier le Mans

orogastric tube

nasogastric tube

Ventilator Associated Pneumonia

Additional relevant MeSH terms:

Pneumonia

Pneumonia, Ventilator-Associated

Study Results

No Results Posted as of Jun 23, 2023