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

NCT ID: NCT02514655

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-15
• Study Completion Date: 2026-12-31

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.

Detailed Description

Multicenter, controlled, prospective randomized open study with blinded assessment of the primary endpoint. Two groups are set up: one experimental group with the control of the cuff pressure by the Nosten® device versus one control group with the manual monitoring of the cuff pressure and inflation of the balloon.

Inclusion: All orotracheally intubated patients for an expected period > 48 hours will be selected. Inclusion will be decided using an algorithm adapted to each center to limit the number of inclusion per month without any biases.

The total number of required insclusion is 500, or 250 / group. This calculation is based on the assumption that a frequency of 25% of patients having at least one VAP in the reference strategy, ensuring a 80% power in the detection by Chi-2 test with a difference 10%. A bilateral risk of first species determined at 5% was considered.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1: Nosten® monitoring

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

2: Manual monitoring

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

Group Type: ACTIVE_COMPARATOR

Manual pressure control

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: DEVICE

Manual pressure control

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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 pregnant or breastfeeding (or with known positive urine pregnancy test before inclusion)
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno MEGARBANE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de Réanimation Médical et Toxicologique

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bruno MEGARBANE, MD, PhD

Role: CONTACT

bruno.megarbane@aphp.fr

(+33)1 49 95 64 91

Facility Contacts

Bruno MEGARBANE, MD, PhD

Role: primary

bruno.megarbane@aphp.fr

(+33)1 49 95 64 91

Other Identifiers

2014-A00190-47

Identifier Type: OTHER

Identifier Source: secondary_id

P111113

Identifier Type: -

Identifier Source: org_study_id