Clinical trial NCT02169193: Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium
Official title: Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Critical Illness
Keywords: microaspiration
mechanical ventilation
enteral feeding
99m technetium
pepsin
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility 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

Primary outcomes:
measure: incidence of pepsin levels ≥200 ng / ml
timeFrame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Secondary outcomes:
measure: likelihood ratio of pepsin of microregurgitation
timeFrame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
measure: likelihood ratio of pepsin of microaspiration
timeFrame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
measure: Youden Index
timeFrame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
measure: ROC curve
timeFrame: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Other outcomes:
Locations:
city: Lille
country: France
facility: ICU, Calmette Hospital, University Hospital of Lille
Study officials:
affiliation: Univ Hosp of Lille, France
name: Saad Nseir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: