Brain Injuries Clinical Trial
— CONTIPRESSOfficial 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
NCT number | NCT03330379 |
Other study ID # | RC16_0390 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | July 31, 2019 |
Verified date | August 2019 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Chu de Nantes | Nantes |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of underinflation episodes | 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 |
Day2 | |
Secondary | incidence of Pcuff >30 cmH2O measurements (overinflation episodes) | 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. |
Within the 2 days following the inclusion | |
Secondary | Duration of mechanical ventilation | Within the 2 days following the inclusion | ||
Secondary | ICU length of stay | Within the 2 days following the inclusion | ||
Secondary | ICU mortality | Within the 2 days following the inclusion | ||
Secondary | occurrence of early ventilator-associated pneumonia | During the first two weeks of hospital stay |
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