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

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02169193
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Radiation: 99mTc-Rhenium Sulfide Nanocolloid	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium
• Study Start Date: Sep 1, 2015
• Anticipated Primary Completion Date: Sep 1, 2016
• Anticipated Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 99mTc-Rhenium Sulfide Nanocolloid 99mTc-Rhenium Sulfide Nanocolloid	Radiation: 99mTc-Rhenium Sulfide Nanocolloid; 12 MBq of NanoCis added to 500 ml of enteral feeding; Other Names: NanoCis

Outcome Measures

Primary Outcome Measures

1. incidence of pepsin levels ≥200 ng / ml [from the start to 6 hours after beginning of 99m technetium labelled enteral feeding]

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

Secondary Outcome Measures

1. likelihood ratio of pepsin of microregurgitation [from the start to 6 hours after beginning of 99m technetium labelled enteral feeding]

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

2. likelihood ratio of pepsin of microaspiration [from the start to 6 hours after beginning of 99m technetium labelled enteral feeding]

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

3. Youden Index [from the start to 6 hours after beginning of 99m technetium labelled enteral feeding]

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

4. ROC curve [from the start to 6 hours after beginning of 99m technetium labelled enteral feeding]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICU, Calmette Hospital, University Hospital of Lille	Lille		France	59037

Sponsors and Collaborators

• University Hospital, Lille

Investigators

• Principal Investigator: Saad Nseir, MD, PhD, Univ Hosp of Lille, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT02169193
• Other Study ID Numbers: 2011_09; 2011-A0140932
• First Posted: Jun 23, 2014
• Last Update Posted: Dec 4, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by University Hospital, Lille: microaspiration; mechanical ventilation; enteral feeding; 99m technetium; pepsin
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Dec 4, 2015