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

Not Applicable

Completed

• Conditions: Acute Brain Injury; Brain Injuries
• Interventions: Device: Tracoe Smart CuffmanagerTM

• Registration Number: NCT03330379
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Start: 2018-03-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of underinflation episodes	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

Name	Time	Method
ICU length of stay	Within the 2 days following the inclusion
Duration of mechanical ventilation	Within the 2 days following the inclusion
ICU mortality	Within the 2 days following the inclusion
occurrence of early ventilator-associated pneumonia	During the first two weeks of hospital stay
incidence of Pcuff >30 cmH2O measurements (overinflation episodes)	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.

Trial Locations

Locations (1)

Chu de Nantes; 🇫🇷 Nantes, France