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

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ClinicalTrials.gov Identifier: NCT02169193
Recruitment Status : Withdrawn
First Posted : June 23, 2014
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critical Illness Radiation: 99mTc-Rhenium Sulfide Nanocolloid Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pepsin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 99mTc-Rhenium Sulfide Nanocolloid
99mTc-Rhenium Sulfide Nanocolloid
 Radiation: 99mTc-Rhenium Sulfide Nanocolloid
12 MBq of NanoCis added to 500 ml of enteral feeding
Other Name: NanoCis


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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)

  4. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169193


Locations
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France
ICU, Calmette Hospital, University Hospital of Lille
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Saad Nseir, MD, PhD Univ Hosp of Lille, France
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02169193    
Other Study ID Numbers: 2011_09
2011-A0140932 ( Other Identifier: ID-RDB number, ANSM )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015
Keywords provided by University Hospital, Lille:
microaspiration
mechanical ventilation
enteral feeding
99m technetium
pepsin
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes