Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium

December 3, 2015 updated by: University Hospital, Lille
Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. We hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard

Study Type

Interventional

Phase

  • 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

  • France
      • Lille, France, 59037
        • ICU, Calmette Hospital, University Hospital of Lille

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > or = 18 years
  • hospitalised in ICU
  • tracheal intubation using a polyvinyl chloride tube and mechanical ventilation
  • predictable mechanical ventilation > or = 6 hours after inclusion
  • enteral nutrition by a nasogastric tube

Exclusion Criteria:

  • refuse to participate to the study
  • no informed consent
  • pregnant
  • contra-indication for enteral nutrition
  • tracheotomy
  • intubation or re-intubation done in 6 hours preceding the inclusion

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
Intervention / Treatment
Experimental: 99mTc-Rhenium Sulfide Nanocolloid
Radiation: 99mTc-Rhenium Sulfide Nanocolloid
12 MBq of NanoCis added to 500 ml of enteral feeding
Other Names:
  • NanoCis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of pepsin levels ≥200 ng / ml
Time Frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Sensibility and sensitivity of Pepsin for the diagnosis of microaspiration will be determined with regard to 99m technetium (gold standard).
from the start to 6 hours after beginning of 99m technetium labelled enteral feeding

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
likelihood ratio of pepsin of microregurgitation
Time Frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Sensibility and sensitivity of Pepsin for the diagnosis of microregurgitation will be determined with regard to 99m technetium.
from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
likelihood ratio of pepsin of microaspiration
Time Frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
positive and negative predictive values, positive and negative likelihood ratio of pepsin for the diagnosis of microaspiration compared to the 99m technetium (gold standard)
from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Youden Index
Time Frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Youden Index and ROC curve analysis of the Pepsin as a marker for the diagnosis of microaspiration compared to the 99m Technetium (gold standard)
from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
ROC curve
Time Frame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Youden Index and ROC curve analysis of the Pepsin as a marker for the diagnosis of microaspiration compared to the 99m Technetium (gold standard)
from the start to 6 hours after beginning of 99m technetium labelled enteral feeding

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

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

September 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011_09
  • 2011-A0140932 (Other Identifier: ID-RDB number, ANSM)

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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