NCT03330379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

October 31, 2017

Last Update Submit

August 30, 2019

Conditions

Acute Brain InjuryBrain Injuries

Keywords

Endotracheal tubeventilator's associated pneumoniaintensive care unitorotracheal intubation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • incidence of Pcuff >30 cmH2O measurements (overinflation episodes)

    Within the 2 days following the inclusion

  • Duration of mechanical ventilation

    Within the 2 days following the inclusion

  • ICU length of stay

    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

Study Arms (2)

continuous adjustment strategy

EXPERIMENTAL

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

usual care

NO INTERVENTION

patients with usual care

Interventions

Tracoe Smart CuffmanagerTMDEVICE

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

continuous adjustment strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • with severe acute brain damage
  • admitted in the ICU for less than 48 hours

You may not qualify if:

  • pregnancy, moribund status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Nantes

Nantes, 44093, France

Location

Related Publications (1)

  • 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.

    PMID: 32376293DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jérôme Dauvergne

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 6, 2017

Study Start

March 1, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

September 4, 2019

Record last verified: 2019-08

Locations

FR(1)