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

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ClinicalTrials.gov Identifier: NCT02514655
Recruitment Status : Recruiting
First Posted : August 4, 2015
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Mechanical Ventilation Tracheal Intubation Ventilator-acquired Pneumonia Intubation -Related Tracheal Lesions Device: Nosten® pressure control (it's not an antibiotic, but simple device) Other: Manual pressure control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Actual Study Start Date : August 15, 2015
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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




Primary Outcome Measures :
  1. Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion) [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: up to 3 months ]
  2. 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) [ Time Frame: up to 3 months ]
  3. Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months) [ Time Frame: up to 3 months ]
  4. Reduction in the periods of hyper-pressure and under-inflation (as long as the patient is intubated during 3 months after inclusion) [ Time Frame: up to 3 months ]
  5. Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months) [ Time Frame: up to 3 months ]
    using the tracheal ischemia score [Touat L. Intensive Care Med 2014]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514655


Contacts
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Contact: Bruno MEGARBANE, MD, PhD (+33)1 49 95 64 91 bruno.megarbane@aphp.fr

Locations
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France
Service de Réanimation Médical et Toxicologique Recruiting
Paris, France, 75010
Contact: Bruno MEGARBANE, MD, PhD    (+33)1 49 95 64 91    bruno.megarbane@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Bruno MEGARBANE, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02514655    
Other Study ID Numbers: P111113
2014-A00190-47 ( Other Identifier: Eudract CT )
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Tracheal intubation
Cuff pressure
Ventilator-acquired pneumonia
Intensive care unit
Tracheal injuries
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Anti-Bacterial Agents
Anti-Infective Agents