NCT05056103: TrachFlush

Automated Secretion Removal in ICU Patients

Terminated NA Last updated 25 July 2022

What this trial tests

NA trial testing TrachFlush in Mechanical Ventilation Complication in 28 participants. Terminated before completion.

Timeline

15 September 2021

Primary endpoint
31 May 2022

30 June 2022

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	15 September 2021
Primary completion	31 May 2022
Estimated completion	30 June 2022
Sites	1 location across Netherlands

Drugs / interventions tested

• TrachFlush

Conditions studied

• Mechanical Ventilation Complication — all drugs for Mechanical Ventilation Complication →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

18 and older, any sex, with Mechanical Ventilation Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

SUMMARY Rationale In intubated and mechanically ventilated critically ill patients, removal of airway secretions is typically performed by tracheal suctioning, an intervention that is labor-intensive and very unpleasant for the patient. The current study tests the hypothesis that a novel secretion removal technology named TrachFlush, that pushes airway secretions past and above the cuff of the endotracheal tube, reduces the need for tracheal suctioning.

Objective The primary objective of this study is to evaluate whether use of the TrachFlush reduces the need for tracheal suctioning. In a selection of patients, one secondary objective is to ascertain the exact volume of airway secretions that is pushed past and above the cuff of the endotracheal tube.

Study design Open prospective intervention study. Study population One hundred adult, intubated and mechanically ventilated ICU patients expected to need invasive ventilation \> 24 hours.

Intervention The attending nurses activate the TrachFlush when there are secretions present in the larger airways that need to be removed. If this results into a push of airway secretions past and above the cuff of the endotracheal tube, no further action is needed. If unsuccessful, the nurse will perform a standard tracheal suctioning procedure to remove the secretions. In a subset of patients with an endotracheal tube that allows subglottal suctioning, the exact amount of airway secretions present above the cuff will be measured each time the TrachFlush is used.

Main study parameters/endpoints The proportion of successful TrachFlush activations from start of the study to complete weaning from the ventilator, or a maximum of 7 days (primary). Secondary endpoints include the total number of TrachFlush activations during the same time window (all patients), and the exact amount of airway secretions pushed past and above the cuff of the endotracheal tube (in patients with a tube allows subglottal suctioning).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness Inappropriate deflation or inflation of the endotracheal cuff by the TrachFlush could cause harm. However, the cuff pressure will be checked regularly, and if necessary corrected, at least every time the TrachFlush has been used. Patients may benefit from the intervention, as the need for tracheal suctioning may reduce.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Prospective, Longitudinal Study Evaluating the Efficacy of an Automated Secretion Removal Technology.
   Sinnige JS, Karbing DS, Valk CMA, Schultz MJ, et al · · 2024 · cited 2× · PMID 38296330 · DOI 10.4187/respcare.11584