Automated Secretion Removal in ICU Patients (TrachFlush)

July 21, 2022 updated by: Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Amsterdam UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: TrachFlush
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.
Other Names:
  • endotracheal suctioning

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
proportion of successful TrachFlush activations from start of the study to complete weaning from the ventilator, or a maximum of 7 days
Time Frame: 7 days
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
total number of TrachFlush activations during the same time window (all patients)
Time Frame: 7 days
7 days
incidence of hypoxemia related to the TrachFlush activation or tracheal suction
Time Frame: 7 days
7 days
Incidence of hypotension related to the TrachFlush activation or tracheal suction
Time Frame: 7 days
7 days
Incidence of patient agitation related to the TrachFlush activation or tracheal suctions
Time Frame: 7 days
7 days
The volume of subglottal secretions with each TrachFlush intervention (in a patients with an endotracheal tube in place that allows subglottic suctioning).
Time Frame: 7days
7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frederique Paulus, PhD, AIDS Malignancy Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TrachFlush

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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