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

Not Applicable

Withdrawn

• Conditions: Critical Illness
• Interventions: Radiation: 99mTc-Rhenium Sulfide Nanocolloid

• Registration Number: NCT02169193
• Lead Sponsor: University Hospital, Lille

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

Study Timeline

• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Study Start: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04
• Primary Completion: 2016-09
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
99mTc-Rhenium Sulfide Nanocolloid	99mTc-Rhenium Sulfide Nanocolloid	99mTc-Rhenium Sulfide Nanocolloid

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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.
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)
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)

Trial Locations

Locations (1)

ICU, Calmette Hospital, University Hospital of Lille; 🇫🇷 Lille, France