Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia (PAV-PROTECT)
Primary Purpose
Mechanical Ventilation, Tracheal Intubation, Ventilator-acquired Pneumonia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nosten® pressure control (it's not an antibiotic, but simple device)
Manual pressure control
Sponsored by
About this trial
This is an interventional prevention trial for Mechanical Ventilation focused on measuring Tracheal intubation, Cuff pressure, Ventilator-acquired pneumonia, Intensive care unit, Tracheal injuries
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.
Sites / Locations
- Service de Réanimation Médical et ToxicologiqueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1: Nosten® monitoring
2: Manual monitoring
Arm Description
One experimental group with the control of the cuff pressure by Nosten® device
One control group with the manual monitoring of the cuff pressure and inflation of the balloon
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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)
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)
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
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]
Full Information
NCT ID
NCT02514655
First Posted
July 7, 2015
Last Updated
August 24, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02514655
Brief Title
Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2015 (Actual)
Primary Completion Date
August 15, 2015 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Tracheal Intubation, Ventilator-acquired Pneumonia, Intubation -Related Tracheal Lesions
Keywords
Tracheal intubation, Cuff pressure, Ventilator-acquired pneumonia, Intensive care unit, Tracheal injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1: Nosten® monitoring
Arm Type
Experimental
Arm Description
One experimental group with the control of the cuff pressure by Nosten® device
Arm Title
2: Manual monitoring
Arm Type
Active Comparator
Arm Description
One control group with the manual monitoring of the cuff pressure and inflation of the balloon
Intervention Type
Device
Intervention Name(s)
Nosten® pressure control (it's not an antibiotic, but simple device)
Intervention Description
One experimental group with the control of the cuff pressure by Nosten® device
Intervention Type
Other
Intervention Name(s)
Manual pressure control
Intervention Description
One control group with the manual monitoring of the cuff pressure and inflation of the balloon
Primary Outcome Measure Information:
Title
Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion)
Description
To prove that the Nosten® device is more effective than monitoring and manual inflation of the catheter balloon in reducing the occurrence of VAP.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
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)
Description
using the bacteriological examination of the tracheal aspiration during the intensive care hospitalization
Time Frame
up to 3 months
Title
Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)
Description
before obtaining microbiological results needed to affirm the Ventilator-Acquired Pneumonia (VAP) according to the criteria of the American Thoracic Society (3 months)
Time Frame
up to 3 months
Title
Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months)
Description
Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)
Time Frame
up to 3 months
Title
Reduction in the periods of hyper-pressure and under-inflation (as long as the patient is intubated during 3 months after inclusion)
Description
Using Nosten® device
Time Frame
up to 3 months
Title
Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months)
Description
using the tracheal ischemia score [Touat L. Intensive Care Med 2014]
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno MEGARBANE, MD, PhD
Phone
(+33)1 49 95 64 91
Email
bruno.megarbane@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno MEGARBANE, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Réanimation Médical et Toxicologique
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno MEGARBANE, MD, PhD
Phone
(+33)1 49 95 64 91
Email
bruno.megarbane@aphp.fr
12. IPD Sharing Statement
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Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
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