Automated Secretion Removal in ICU Patients

Mechanical Ventilation Complication Clinical Trial

— TrachFlush  

Official title:

Effect of an Automated Secretion Removal Technology, Named TrachFlush, on the Need for Tracheal Suctioning - Protocol for a Study in Intubated and Mechanically Ventilated Intensive Care Unit Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05056103
• Other study ID #: TrachFlush
• Status: Terminated
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• admission to one of the participating ICUs;

• intubated with an endotracheal tube containing a cuff;

• receiving invasive mechanical ventilation; and

• expected to need invasive ventilation beyond the following calendar day at the moment of inclusion.

Exclusion Criteria:

• age < 18 years;

• known or suspected tracheal damage, e.g., after inhalation trauma, thorax trauma, or intubation trauma;

• any condition for which deflation of the endotracheal cuff is deemed detrimental, e.g., in case high airway pressures are needed; and

• any infection, or colonization with pathogens that require strict single isolation of the patient (cohort isolation is allowed).

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• TrachFlush
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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of successful TrachFlush activations from start of the study to complete weaning from the ventilator, or a maximum of 7 days		7 days
Secondary	total number of TrachFlush activations during the same time window (all patients)		7 days
Secondary	incidence of hypoxemia related to the TrachFlush activation or tracheal suction		7 days
Secondary	Incidence of hypotension related to the TrachFlush activation or tracheal suction		7 days
Secondary	Incidence of patient agitation related to the TrachFlush activation or tracheal suctions		7 days
Secondary	The volume of subglottal secretions with each TrachFlush intervention (in a patients with an endotracheal tube in place that allows subglottic suctioning).		7days