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

NCT02169193 | Withdrawn

• 2 other identifiers: 2011_092011-A0140932
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

microaspiration; mechanical ventilation; enteral feeding; 99m technetium; pepsin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• likelihood ratio of pepsin of microregurgitation

  from the start to 6 hours after beginning of 99m technetium labelled enteral feeding

• likelihood ratio of pepsin of microaspiration

  from the start to 6 hours after beginning of 99m technetium labelled enteral feeding

• Youden Index

  from the start to 6 hours after beginning of 99m technetium labelled enteral feeding

• ROC curve

  from the start to 6 hours after beginning of 99m technetium labelled enteral feeding

Study Arms (1)

99mTc-Rhenium Sulfide Nanocolloid

EXPERIMENTAL

99mTc-Rhenium Sulfide Nanocolloid

Radiation: 99mTc-Rhenium Sulfide Nanocolloid

Interventions

99mTc-Rhenium Sulfide Nanocolloid RADIATION

12 MBq of NanoCis added to 500 ml of enteral feeding

Also known as: NanoCis

99mTc-Rhenium Sulfide Nanocolloid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> or = 18 years
• hospitalised in ICU
• tracheal intubation using a polyvinyl chloride tube and mechanical ventilation
• enteral nutrition by a nasogastric tube

You may not qualify if:

• refuse to participate to the study
• no informed consent
• pregnant
• contra-indication for enteral nutrition
• tracheotomy

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

ICU, Calmette Hospital, University Hospital of Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Critical Illness

Interventions

nanocis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saad Nseir, MD, PhD

  Univ Hosp of Lille, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 23, 2014
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: January 1, 2017
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

FR (1)