Diagnosis of Microaspiration in Intubated Critically Ill... | NCT02169193

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

NCT02169193

Sponsor

University Hospital, Lille

Status

Withdrawn

Last Update Posted

Dec 4, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Critical Illness

Interventions

99mTc-Rhenium Sulfide Nanocolloid

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-A0140932	Other Identifier	ID-RDB number, ANSM

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Sep 2016Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Jun 18, 2014

First Submission Date that Met QC Criteria

Jun 20, 2014

First Posted Date

Jun 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2015

Last Update Posted Date

Dec 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
99mTc-Rhenium Sulfide Nanocolloid	Experimental	99mTc-Rhenium Sulfide Nanocolloid	Radiation: 99mTc-Rhenium Sulfide Nanocolloid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
99mTc-Rhenium Sulfide Nanocolloid	Radiation	12 MBq of NanoCis added to 500 ml of enteral feeding	99mTc-Rhenium Sulfide Nanocolloid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
likelihood ratio of pepsin of microaspiration

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Saad Nseir, MD, PhD	Univ Hosp of Lille, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ICU, Calmette Hospital, University Hospital of Lille		Lille		59037	France

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C512413	nanocis

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided