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

Mechanical Ventilation Clinical Trial

— PAV-PROTECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02514655
• Other study ID #: P111113
• Secondary ID: 2014-A00190-47
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bruno MEGARBANE, MD, PhD
• Phone: (+33)1 49 95 64 91
• Email: bruno.megarbane[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2023
• Est. primary completion date: August 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Service de Réanimation Médical et Toxicologique	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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