Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP) and early tracheal lesions resulting from intubation with decreased discomfort, morbidity, and nursing workload.

The main objective of the investigators is to show that Nosten® device is more effective than monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP occurrence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥18 years

Patients admitted in the ICU, mechanically ventilated and whose trachea was intubated by the oral route using tubes with catheter polyvinyl chloride "high-volume low pressure" and of standard shape tubes Intubation indication is decided by the physicians in charge according to the usual criteria of respiratory, neurological and /or hemodynamic failure

With an expected duration of mechanical ventilation > 48 hours

Disqualifiers

Patients intubated by nasotracheal route

Patients with tracheotomy before admission

Patients intubated with a polyurethane balloon catheter or a polyvinyl chloride balloon catheter of conical shape

Previously intubated patients for > 48 hours before their possible recruitment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nosten® pressure control (it's not an antibiotic, but simple device)

    Device

    One experimental group with the control of the cuff pressure by Nosten® device

  • Manual pressure control

    Other intervention

    One control group with the manual monitoring of the cuff pressure and inflation of the balloon

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: 1: Nosten® monitoringExperimental treatment 1 intervention
Group B: 2: Manual monitoringActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion)

To prove that the Nosten® device is more effective than monitoring and manual inflation of the catheter balloon in reducing the occurrence of VAP.

Time frame
up to 3 months

Secondary outcomes

1

Reduction in the tracheobronchial bacterial colonization assessed using the bacteriological examination of the tracheal aspiration (as long as the patient is intubated during 3 months after inclusion)

using the bacteriological examination of the tracheal aspiration during the intensive care hospitalization

Time frame
up to 3 months
2

Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)

before obtaining microbiological results needed to affirm the Ventilator-Acquired Pneumonia (VAP) according to the criteria of the American Thoracic Society (3 months)

Time frame
up to 3 months
3

Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months)

Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)

Time frame
up to 3 months
4

Reduction in the periods of hyper-pressure and under-inflation (as long as the patient is intubated during 3 months after inclusion)

Using Nosten® device

Time frame
up to 3 months

Other outcomes

Sponsors and contacts

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