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Comparison of Two Strategies for Endotracheal Tube Cuff Underinflation Prevention During Invasive Mechanical Ventilation (CONTIPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330379
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control.

Condition or disease Intervention/treatment Phase
Acute Brain Injury Brain Injuries Device: Tracoe Smart CuffmanagerTM Not Applicable

Detailed Description:
During invasive mechanical ventilation, maintaining a tracheal cuff pressure (Pcuff) around 25 cmH2O is recommended to prevent cuff over- (> 30 cmH2O) and underinflation (< 20 cmH2O), identified as risk factors for tracheal ischemic damage and for oropharyngeal microaspirations, respectively. Intermittent measurements with intermittent adjustments of Pcuff is the widely used strategy but, between measurements, over- and underinflation episodes could occur. Devices allowing a continuous control of Pcuff are therefore appealing. As microaspiration is the most relevant mechanism for ventilator-associated pneumonia (VAP), the use of such devices may decrease the incidence of VAP for instance. To the knowledge of the investigators, the continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control. As secondary objectives, the investigators aim to assess the impact of the use of the Tracoe Smart CuffmanagerTM on the incidence of overinflation episodes and on the incidence of early ventilator-associated pneumonia. A homogenous population will be studied for this purpose: patients admitted with severe acute brain damage.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Two Strategies for the Prevention of Endotracheal Tube Cuff Underinflation During Invasive Mechanical Ventilation: Intermittent Versus Continuous Cuff Pressure Control - A Randomised Controlled Study
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: continuous adjustment strategy
patients assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff
Device: Tracoe Smart CuffmanagerTM
In patients randomly assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff. Within the 2 days following the inclusion, all the intermittent Pcuff measurements will be collected as well as the incidence of Pcuff manual adjustments

No Intervention: usual care
patients with usual care



Primary Outcome Measures :
  1. Incidence of underinflation episodes [ Time Frame: Day2 ]

    The primary outcome is to test whether the Tracoe Smart CuffmanagerTM reduces the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control. Therefore, a comparison, between the 2 groups, of the incidence of Pcuff <20 cmH2O measurements will be performed.

    Time Frame: Within the 2 days following the inclusion, all the intermittent Pcuff measurements will be collected as well as the incidence of Pcuff manual adjustments



Secondary Outcome Measures :
  1. incidence of Pcuff >30 cmH2O measurements (overinflation episodes) [ Time Frame: Within the 2 days following the inclusion ]

    As secondary objective, a comparison, between the 2 groups, of the incidence of Pcuff >30 cmH2O measurements (overinflation episodes) will be performed.

    Furthermore, the incidence of early ventilator-associated pneumonia will be compared between the 2 groups.


  2. Duration of mechanical ventilation [ Time Frame: Within the 2 days following the inclusion ]
  3. ICU length of stay [ Time Frame: Within the 2 days following the inclusion ]
  4. ICU mortality [ Time Frame: Within the 2 days following the inclusion ]
  5. occurrence of early ventilator-associated pneumonia [ Time Frame: During the first two weeks of hospital stay ]


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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:

  • with severe acute brain damage
  • admitted in the ICU for less than 48 hours
  • and expected to receive invasive mechanical ventilation (through orotracheal tube with a low pressure-high volume cuff) for at least 48 hours after inclusion.

Exclusion Criteria:

  • change in the upper airway management within the 48 hours following the inclusion (extubation or change in the tracheal tube or tracheostomy)
  • pregnancy, moribund status.

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): NCT03330379


Locations
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France
Chu de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Jérôme Dauvergne Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03330379    
Other Study ID Numbers: RC16_0390
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Endotracheal tube
ventilator's associated pneumonia
intensive care unit
orotracheal intubation
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System