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

NCT02514655 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-06-25

No results posted yet for this study

Summary

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.

Conditions

  • Mechanical Ventilation
  • Tracheal Intubation
  • Ventilator-acquired Pneumonia
  • Intubation -Related Tracheal Lesions

Interventions

DEVICE

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

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

OTHER

Manual pressure control

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bruno MEGARBANE, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-15
Primary Completion
2015-08-15
Completion
2026-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02514655 on ClinicalTrials.gov