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

June 14, 2023 updated by: Centre Hospitalier le Mans

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Le Mans, France, 72000
        • Centre Hospitalier Du Mans
        • Contact:
        • Principal Investigator:
          • Josselin SALETES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 peumoniae
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier le Mans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHM-2022/S03/05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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