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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Brain Injuries; Acute Brain Injury

Treatments: Device: Tracoe Smart CuffmanagerTM

Study type: Interventional

Funder types: Other

Identifiers

NCT03330379

RC16_0390

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

continuous adjustment strategy

Experimental group

Description:

patients assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff

Treatment:

Device: Tracoe Smart CuffmanagerTM

usual care

No Intervention group

Description:

patients with usual care