Validation of Aspiration Markers

March 14, 2016 updated by: Lorenzo Berra, MD, Massachusetts General Hospital

Validation of a Marker for Aspiration and Endotracheal Tube Cuff Leak.

This is an interventional crossover study aimed at validating diatom shells as a marker for cuff leak and microaspiration in mechanically ventilated, critically ill patients.

Study Overview

Status

Status

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Withdrawn

Conditions

Conditions

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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.

Detailed Description

At present there is no standard method for the evaluation of in vivo cuff leak and aspiration. Most of the tested techniques have major pitfalls that render their routine application infeasible. Lacking a practical and reliable marker, any possible intervention aimed at improving cuff seal and ETT performance in order to reduce VAP occurrence is going to be hindered by the inability to truly evaluate its efficacy. Radiolabeled markers are expensive, expose the patient to considerable radiological risk, and require transport to a radiological department, which would expose critically ill patients to additional risk. Dyes have the potential to give useful information about the presence of a cuff leak, but due to persistent staining of secretions, they do not allow continuous monitoring of aspiration. Amylase detection could be a good marker of aspiration, but its ability to detect aspiration is poor even when compared to pepsin. Pepsin and bile acids have the potential to detect some of the aspirations and cuff leaks that happen daily in mechanically ventilated patients, but due to their gastrointestinal nature, they do not offer any kind of information about aspiration of contaminated oropharyngeal secretions. With this research protocol, we would like to validate the use of diatom skeletons suspended in saline as a marker for determining cuff leakage and aspiration events in an ICU population and compare its efficacy in identifying aspiration events with pepsin detection. Diatoms are a major group of algae, composing the majority of phytoplankton. Their diameter is 5-15 μm on average and 1 ml of seawater usually contains about 104 diatoms. They are unicellular organisms and their main feature is that they are enclosed within a cell wall made of amorphous silica, biopolymerized in a geometric fashion that is species-dependent. At the end of their vital cycle, diatom shells deposit at the bottom of the sea. Diatom shell deposits have been found in almost every place on Earth, and are the main component of diatomaceous earth (DE). DE is an extremely fine powder composed of diatom shells that have accumulated over thousands of years. Due to its microscopical texture and inexpensive nature, it is commonly employed as a filtering media for beverages and a drying and anti-mold agent for cereals. Diatom shells compose food-grade DE in its entirety. Due to its non-crystalline, amorphous nature, it is essentially nontoxic. Our hypothesis is that administration of 10 mg of DE suspended in 10 ml of saline into the pharyngeal cavity of intubated patients will act as a reliable marker of cuff leak and aspiration in critically ill patients. Thanks to their geometric shape, diatom shells should be easily detectable in tracheal secretions when observed under a microscope. The number of diatoms-per-field observed under a fixed magnification will allow for the detection of microaspiration in a qualitative and quantitative way. The introduction of this new, safe and inexpensive marker for evaluating ETT cuff performance and for detecting aspiration will improve the design of future studies aimed at VAP prevention

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

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.
  • Phase 1

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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:

  1. Age ≥ 18 years;
  2. Admission to Surgical ICUs (Ellison 4 or Blake 12);
  3. Patients expected to be intubated for at least 48 hours or longer from the time of enrollment.

Exclusion Criteria:

  1. High PEEP requirement at enrollment (PEEP higher than 8 cmH2O)
  2. Diagnosis of ARDS (any severity)
  3. Status asthmaticus
  4. Current or past participation in another interventional trial conflicting with the present study;
  5. Pregnant women;
  6. Prisoner status;
  7. Patients who had partial or total gastrectomy.

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: Diagnostic
  • 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.
Experimental: Suspended Diatoms
Suspended diatom shells (10 mg/ 10 ml of saline) will be instilled in the oral cavity of the study subject every 12 hours for the first three study days. The total amount of amorphous silica administered will be 20 mg/day, which is the average daily intake of amorphous silica in normal human diet (0.3 mg/kg body weight/day)
Drug: Diatoms Shells
Instillation of suspended diatom shells - 10 mg q12h

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
Measure Description
Time Frame
Cuff leak and microaspiration
Time Frame: 3 days
The investigators will collect samples of tracheal secretions below the cuff every 4 hours after the first pharyngeal administration of diatom shells and after 12 hours from the other 5 scheduled administrations of diatom shells. Samples will be centrifuged and the sediment observed under microscopy for detection of shells in tracheal secretions below the endotracheal tube cuff. Their presence will be a sign of cuff leak and aspiration. The ratio between administered diatom shells and collected diatom shells will be used to give an estimate of leakage.
3 days

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.
Massachusetts General Hospital

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

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.
February 1, 2016

Primary Completion (Anticipated)

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.
March 1, 2016

Study Completion (Anticipated)

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.
March 1, 2016

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).
November 23, 2014

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.
November 25, 2014

First Posted (Estimate)

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.
November 26, 2014

Study Record Updates

Last Update Posted (Estimate)

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.
March 16, 2016

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.
March 14, 2016

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.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • Creatures

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