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

Primary Purpose

Critical Illness

Status

Withdrawn

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

99mTc-Rhenium Sulfide Nanocolloid

About this trial

This is an interventional diagnostic trial for Critical Illness focused on measuring microaspiration, mechanical ventilation, enteral feeding, 99m technetium, pepsin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ICU, Calmette Hospital, University Hospital of Lille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

99mTc-Rhenium Sulfide Nanocolloid

Arm Description

99mTc-Rhenium Sulfide Nanocolloid

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

likelihood ratio of pepsin of microregurgitation

Sensibility and sensitivity of Pepsin for the diagnosis of microregurgitation will be determined with regard to 99m technetium.

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)

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)

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)

Full Information

NCT ID

NCT02169193

First Posted

June 18, 2014

Last Updated

December 3, 2015

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT02169193

Brief Title

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

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Withdrawn

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

99mTc-Rhenium Sulfide Nanocolloid

Arm Type

Experimental

Arm Description

99mTc-Rhenium Sulfide Nanocolloid

Intervention Type

Radiation

Intervention Name(s)

99mTc-Rhenium Sulfide Nanocolloid

Other Intervention Name(s)

NanoCis

Intervention Description

12 MBq of NanoCis added to 500 ml of enteral feeding

Primary Outcome Measure Information:

Title

incidence of pepsin levels ≥200 ng / ml

Description

Sensibility and sensitivity of Pepsin for the diagnosis of microaspiration will be determined with regard to 99m technetium (gold standard).

Time Frame

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

Secondary Outcome Measure Information:

Title

likelihood ratio of pepsin of microregurgitation

Description

Sensibility and sensitivity of Pepsin for the diagnosis of microregurgitation will be determined with regard to 99m technetium.

Time Frame

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

Title

likelihood ratio of pepsin of microaspiration

Description

positive and negative predictive values, positive and negative likelihood ratio of pepsin for the diagnosis of microaspiration compared to the 99m technetium (gold standard)

Time Frame

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

Title

Youden Index

Description

Youden Index and ROC curve analysis of the Pepsin as a marker for the diagnosis of microaspiration compared to the 99m Technetium (gold standard)

Time Frame

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

Title

ROC curve

Description

Youden Index and ROC curve analysis of the Pepsin as a marker for the diagnosis of microaspiration compared to the 99m Technetium (gold standard)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saad Nseir, MD, PhD

Organizational Affiliation

Univ Hosp of Lille, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

ICU, Calmette Hospital, University Hospital of Lille

City

Lille

ZIP/Postal Code

59037

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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