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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation; Ventilator-acquired Pneumonia; Tracheal Intubation; Intubation -Related Tracheal Lesions
• Intervention / Treatment: Device: Nosten® pressure control (it's not an antibiotic, but simple device); Other: Manual pressure control

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno MEGARBANE, MD, PhD; Phone Number: (+33)1 49 95 64 91; Email: bruno.megarbane@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Service de Réanimation Médical et Toxicologique
    • Contact: Bruno MEGARBANE, MD, PhD; Phone Number: (+33)1 49 95 64 91; Email: bruno.megarbane@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1: Nosten® monitoring; 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); One experimental group with the control of the cuff pressure by Nosten® device
Active Comparator: 2: Manual monitoring; One control group with the manual monitoring of the cuff pressure and inflation of the balloon	Other: Manual pressure control; One control group with the manual monitoring of the cuff pressure and inflation of the balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 3 months
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)	up to 3 months
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)	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)	Using Nosten® device	up to 3 months
Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months)	using the tracheal ischemia score [Touat L. Intensive Care Med 2014]	up to 3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Bruno MEGARBANE, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2015
• Primary Completion (Actual): August 15, 2015
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimated): August 4, 2015

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Intensive care unit; Tracheal intubation; Cuff pressure; Ventilator-acquired pneumonia; Tracheal injuries
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: P111113; 2014-A00190-47 (Other Identifier: Eudract CT)