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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02169193
Other study ID # 2011_09
Secondary ID 2011-A0140932
Status Withdrawn
Phase N/A
First received June 18, 2014
Last updated December 3, 2015
Start date September 2015
Est. completion date January 2017

Study information

Verified date December 2015
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Withdrawn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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Radiation:
99mTc-Rhenium Sulfide Nanocolloid
12 MBq of NanoCis added to 500 ml of enteral feeding

Locations

Country Name City State
France ICU, Calmette Hospital, University Hospital of Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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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