NCT02301845|WithdrawnPhase 1
Study Stopped
IRB disapproval
Validation of Aspiration Markers
Validation of a Marker for Aspiration and Endotracheal Tube Cuff Leak.
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Sponsor study identifier
interventional
0
1 country
1
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2014
Actual (reported)November 26, 2014
Actual (reported)February 2016
Date type not reportedThis date has not been verified as actual or estimated.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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)
Instillation of suspended diatom shells - 10 mg q12h
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Lorenzo Berra, MD
Massachusetts General Hospital
0 participants (actual enrollment reported by the registry).
First Submitted
November 23, 2014
First Posted
November 26, 2014
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of Surface Landmark Palpation for Identification of the Cricoid Cartilage in Obstetric Patients
Contact the study team to confirm eligibility.
Primary Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 16, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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