Clinical trial NCT03330379: Comparison of Two Strategies for Endotracheal Tube Cuff Underinflation Prevention During Invasive Mechanical Ventilation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Brain Injury
Brain Injuries
Keywords: Endotracheal tube
ventilator's associated pneumonia
intensive care unit
orotracheal intubation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of underinflation episodes
timeFrame: Day2
Secondary outcomes:
measure: incidence of Pcuff >30 cmH2O measurements (overinflation episodes)
timeFrame: Within the 2 days following the inclusion
measure: Duration of mechanical ventilation
timeFrame: Within the 2 days following the inclusion
measure: ICU length of stay
timeFrame: Within the 2 days following the inclusion
measure: ICU mortality
timeFrame: Within the 2 days following the inclusion
measure: occurrence of early ventilator-associated pneumonia
timeFrame: During the first two weeks of hospital stay
Other outcomes:
Locations:
city: Nantes
country: France
facility: Chu de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Jérôme Dauvergne
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dauvergne JE, Geffray AL, Asehnoune K, Rozec B, Lakhal K. Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study. Anaesth Crit Care Pain Med. 2020 Jun;39(3):435-441. doi: 10.1016/j.accpm.2020.04.007. Epub 2020 May 4.