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

NCT ID: NCT02169193

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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

Conditions

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Critical Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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99mTc-Rhenium Sulfide Nanocolloid

99mTc-Rhenium Sulfide Nanocolloid

Group Type EXPERIMENTAL

99mTc-Rhenium Sulfide Nanocolloid

Intervention Type RADIATION

12 MBq of NanoCis added to 500 ml of enteral feeding

Interventions

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99mTc-Rhenium Sulfide Nanocolloid

12 MBq of NanoCis added to 500 ml of enteral feeding

Intervention Type RADIATION

Other Intervention Names

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NanoCis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saad Nseir, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Univ Hosp of Lille, France

Locations

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ICU, Calmette Hospital, University Hospital of Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2011-A0140932

Identifier Type: OTHER

Identifier Source: secondary_id

2011_09

Identifier Type: -

Identifier Source: org_study_id