Automated Secretion Removal in ICU Patients

NCT05056103 | Terminated DMC

• 1 other identifier: TrachFlush
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• total number of TrachFlush activations during the same time window (all patients)

  7 days

• incidence of hypoxemia related to the TrachFlush activation or tracheal suction

  7 days

• Incidence of hypotension related to the TrachFlush activation or tracheal suction

  7 days

• Incidence of patient agitation related to the TrachFlush activation or tracheal suctions

  7 days

• The volume of subglottal secretions with each TrachFlush intervention (in a patients with an endotracheal tube in place that allows subglottic suctioning).

  7days

Study Arms (1)

TrachFlush

OTHER

Device: TrachFlush

Interventions

TrachFlush DEVICE

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.

Also known as: endotracheal suctioning

TrachFlush

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• admission to one of the participating ICUs;
• intubated with an endotracheal tube containing a cuff;
• receiving invasive mechanical ventilation; and

You may not qualify if:

• 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).

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, 1105AZ, Netherlands

Location

Study Officials

• Frederique Paulus, PhD

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 24, 2021
• Study Start: September 15, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

NL (1)