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

NCT02514655 | Recruiting

• 2 other identifiers: P1111132014-A00190-47
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tracheal intubation; Cuff pressure; Ventilator-acquired pneumonia; Intensive care unit; Tracheal injuries

Outcome Measures

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.

  up to 3 months

Secondary Outcomes (5)

• 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)

  up to 3 months

• Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)

  up to 3 months

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

  up to 3 months

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

  up to 3 months

• Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months)

  up to 3 months

Study Arms (2)

1: Nosten® monitoring

EXPERIMENTAL

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

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

2: Manual monitoring

ACTIVE COMPARATOR

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

Other: Manual pressure control

Interventions

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

1: Nosten® monitoring

Manual pressure control OTHER

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

2: Manual monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Moribund patients (terminal illness or care-limiting decision)
• Minors protected or incapacitated patients
• Patients with recently diagnosed ENT cancer
• Patients with facial, thoracic, spinal or upper airway trauma
• Patients burned, intoxicated by fire fumes or caustic ingestion
• Patient intubated with a subglottic suction tube
• Unaffiliated patients to a social security
• Patients included in any other scientific study that may interfere with the outcome criteria of this study. This includes any other study on tracheal intubation or mechanical ventilation, if the use of the pressure control device may interfere with its endpoint.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Réanimation Médical et Toxicologique

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno MEGARBANE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno MEGARBANE, MD, PhD

CONTACT

(+33)1 49 95 64 91; bruno.megarbane@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: August 4, 2015
• Study Start: August 15, 2015
• Primary Completion: August 15, 2015
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 25, 2025

Record last verified: 2023-08

Locations

FR (1)