NCT02598713

Brief Summary

The goal of this interventional study is to test Quinine as marker of aspiration (endotracheal tube \[ETT\] cuff leakage) in mechanically ventilated, critically ill patients.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

8.6 years

First QC Date

November 2, 2015

Last Update Submit

November 24, 2025

Conditions

PneumoniaAspiration

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal aspiration: change in concentration of quinine in tracheal samples.

    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.

    After the beginning of the study, samples will be collected at hours: 0,1 and 24, 25

Study Arms (1)

Aspiration Markers

EXPERIMENTAL

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.

Drug: Aspiration Marker

Interventions

Aspiration MarkerDRUG

Instillation of Quinine suspended in sterile water in the retropharyngeal space of intubated ICU admitted patients for two consecutive days.

Aspiration Markers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachussets General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

  • 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.

    PMID: 11934711BACKGROUND

  • 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.

    PMID: 12768164BACKGROUND

  • 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.

    PMID: 10232424BACKGROUND

  • 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.

    PMID: 25500677BACKGROUND

  • 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.

    PMID: 16484901BACKGROUND

  • 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.

    PMID: 23709196BACKGROUND

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lorenzo Berra, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 6, 2015

Study Start

December 1, 2015

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations

US(1)