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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Critical Illness

Intervention / Treatment
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* Radiation: 99mTc-Rhenium Sulfide Nanocolloid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc-Rhenium Sulfide Nanocolloid<br>99mTc-Rhenium Sulfide Nanocolloid | Radiation: 99mTc-Rhenium Sulfide Nanocolloid<br>* 12 MBq of NanoCis added to 500 ml of enteral feeding<br>* Other names: NanoCis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pepsin levels ≥200 ng / ml | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microaspiration, mechanical ventilation, enteral feeding, 99m technetium, pepsin