Critical Illness Clinical Trial
Official title:
Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | ICU, Calmette Hospital, University Hospital of Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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