Validation of Aspiration Markers

NCT02301845 | Withdrawn Phase 1

• 1 other identifier: Creatures
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia, Aspiration

Keywords

Respiration, artificial

Outcome Measures

Primary Outcomes (1)

• Cuff leak and microaspiration

  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

Study Arms (1)

Suspended Diatoms

EXPERIMENTAL

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

Interventions

Diatoms Shells DRUG

Instillation of suspended diatom shells - 10 mg q12h

Suspended Diatoms

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pneumonia, Aspiration; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorenzo Berra, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthetist

Study Record Dates

• First Submitted: November 23, 2014
• First Posted: November 26, 2014
• Study Start: February 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

US (1)