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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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• Status: Withdrawn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

• Critical Illness

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