Critical Illness
Conditions
Keywords
microaspiration, mechanical ventilation, enteral feeding, 99m technetium, pepsin
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.
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
Interventions
RADIATION99mTc-Rhenium Sulfide Nanocolloid
12 MBq of NanoCis added to 500 ml of enteral feeding
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of pepsin levels ≥200 ng / ml | 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
| Measure | Time frame | Description |
|---|---|---|
| likelihood ratio of pepsin of microregurgitation | 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. |
| likelihood ratio of pepsin of microaspiration | 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) |
| Youden Index | 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) |
| ROC curve | 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) |
Countries
France
Outcome results
None listed