- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598713
Validation of Aspiration Markers in Intubated Patients
Validation of Markers for Aspiration for Endotracheal Tube Cuff Leak
Study Overview
Detailed Description
At present there is no standard method for the evaluation of in vivo cuff leak and aspiration. Most of the tested techniques have major pitfalls that render their routine application infeasible. Lacking a practical and reliable marker, any possible intervention aimed at improving cuff seal and ETT performance in order to reduce VAP occurrence is going to be hindered by the inability to truly evaluate its efficacy. Radio-labeled markers are expensive, expose the patient to considerable radiological risk, and require transport to a radiological department, which would expose critically ill patients to additional risk. Dyes have the potential to give useful information about the presence of a cuff leak, but due to persistent staining of secretions, they do not allow continuous monitoring of aspiration. Amylase detection could be a good marker of aspiration, but its ability to detect aspiration is poor even when compared to pepsin. Pepsin and bile acids have the potential to detect some of the aspirations and cuff leaks that happen daily in mechanically ventilated patients, but due to their gastrointestinal nature, they do not offer any kind of information about aspiration of contaminated oropharyngeal secretions. With this research protocol, the investigators would like to validate the use of Quinine suspended in sterile water as marker for determining cuff leakage and aspiration events in an ICU population. Quinine is compound commonly used in food manufacturing. His pharmacokinetic and -dynamic has extensively been studied. The chemical structure of this molecule allows the detection up to pico-molar concentration by spectrophotometry.
The investigators will challenge the oropharyngeal cavity with a known concentration of Quinine suspended in sterile water. The investigators hypothesized that the detection by spectrophotometry of the same substance in the tracheal secretions will prove aspiration.
The investigators specific aims are:
- To quantify the measurements of Quinine in the tracheal sample and compare with the measurements of Quinine in the oral sample.
- To assess association between the amount of oropharyngeal aspiration and the development of upper and lower respiratory complications (i.e. ventilator associated pneumonia [VAP], tracheobronchitis, ventilator-associated events, acute respiratory distress syndrome [ARDS], etc.).
- To determine patient's risk factors associated with oropharyngeal aspiration. The introduction of this new, safe and inexpensive markers for evaluating ETT cuff performance and for detecting aspiration will improve the design of future studies aimed at VAP prevention.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Lorenzo Berra, MD
- Phone Number: Lorenzo Berra, MD
- Email: lberra@partners.org
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachussets General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years
- Admission to Surgical ICUs (MGH Ellison 4 or Blake 12)
- Patients expected to be intubated for at least 48 hours or longer from the time of enrollment.
Exclusion Criteria:
- High PEEP requirement at enrollment (PEEP higher than 8 cmH2O)
- Diagnosis of ARDS (any severity)
- Status asthmatics
- Current or past participation in another interventional trial conflicting with the present study
- Pregnant women
- Prisoner status
- Patients who had partial or total gastrectomy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aspiration Markers
Aspiration marker solution will be composed as following: Quinine 83 mg/L suspended in sterile water.
After enrollment patients will be challenged with 5 mL of the study solution nebulized in the retropharyngeal space twice a day for two consecutive days.
|
Instillation of Quinine suspended in sterile water in the retropharyngeal space of intubated ICU admitted patients for two consecutive days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oropharyngeal aspiration: change in concentration of quinine in tracheal samples.
Time Frame: After the beginning of the study, samples will be collected at hours: 0,1 and 24, 25
|
The investigators will collect samples of oral and tracheal secretions below the endotracheal tube's cuff.
Samples will be centrifuged and the supernatant tested by spectrophotometry.
The presence of the study compound in the tracheal samples will be a sign of cuff leak and aspiration.
The ratio between the concentration of the study molecules in the oral sample and in the collected samples will be used to give an estimate of leakage.
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After the beginning of the study, samples will be collected at hours: 0,1 and 24, 25
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.
- Berra L, Panigada M, De Marchi L, Greco G, Z -Xi Y, Baccarelli A, Pohlmann J, Costello KF, Appleton J, Mahar R, Lewandowski R, Ravitz L, Kolobow T. New approaches for the prevention of airway infection in ventilated patients. Lessons learned from laboratory animal studies at the National Institutes of Health. Minerva Anestesiol. 2003 May;69(5):342-7.
- Feldman C, Kassel M, Cantrell J, Kaka S, Morar R, Goolam Mahomed A, Philips JI. The presence and sequence of endotracheal tube colonization in patients undergoing mechanical ventilation. Eur Respir J. 1999 Mar;13(3):546-51. doi: 10.1183/09031936.99.13354699.
- Li Bassi G, Luque N, Marti JD, Aguilera Xiol E, Di Pasquale M, Giunta V, Comaru T, Rigol M, Terraneo S, De Rosa F, Rinaudo M, Crisafulli E, Peralta Lepe RC, Agusti C, Lucena C, Ferrer M, Fernandez L, Torres A. Endotracheal tubes for critically ill patients: an in vivo analysis of associated tracheal injury, mucociliary clearance, and sealing efficacy. Chest. 2015 May;147(5):1327-1335. doi: 10.1378/chest.14-1438.
- Metheny NA, Clouse RE, Chang YH, Stewart BJ, Oliver DA, Kollef MH. Tracheobronchial aspiration of gastric contents in critically ill tube-fed patients: frequency, outcomes, and risk factors. Crit Care Med. 2006 Apr;34(4):1007-15. doi: 10.1097/01.CCM.0000206106.65220.59.
- Mietto C, Pinciroli R, Patel N, Berra L. Ventilator associated pneumonia: evolving definitions and preventive strategies. Respir Care. 2013 Jun;58(6):990-1007. doi: 10.4187/respcare.02380.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aspiration Markers
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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