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Quinine Aspiration Marker for Detecting Airway Leaks

Phase 1

Recruiting

Led By Lorenzo Berra, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trialtests if Quinine can detect if air escapes from a tube placed in a patient's airway during mechanical ventilation.

Who is the study for?

This trial is for adults over 18 who are in surgical intensive care units and expected to be on a ventilator for at least 48 hours. It's not open to pregnant women, prisoners, those with severe lung injury (ARDS), high oxygen needs, asthma attacks, or who've had stomach surgery.Check my eligibility

What is being tested?

The study is testing Quinine as a marker to detect saliva or stomach contents entering the lungs (aspiration) in patients on mechanical ventilation. The focus is on whether Quinine can indicate if the tube cuff isn't sealing properly.See study design

What are the potential side effects?

While specific side effects of using Quinine as an aspiration marker aren't detailed here, common reactions may include digestive upset, headache, disturbed vision or hearing; however these will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after the beginning of the study, samples will be collected at hours: 0,1 and 24, 25

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after the beginning of the study, samples will be collected at hours: 0,1 and 24, 25

This trial's timeline: 3 weeks for screening, Varies for treatment, and after the beginning of the study, samples will be collected at hours: 0,1 and 24, 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aspiration MarkersExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,461 Total Patients Enrolled

16 Trials studying Pneumonia

178,784 Patients Enrolled for Pneumonia

Lorenzo Berra, MDPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital, Massachusetts General Physicians Organization Inc

16 Previous Clinical Trials

814 Total Patients Enrolled

1 Trials studying Pneumonia

Media Library

Quinine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02598713 — Phase 1

Quinine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02598713 — Phase 1

Pneumonia Research Study Groups: Aspiration Markers

Pneumonia Clinical Trial 2023: Quinine Highlights & Side Effects. Trial Name: NCT02598713 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities remaining to join this experiment?

"Per the details on clinicaltrials.gov, this study is presently enrolling participants; it was initially posted in December 2015 and last amended in November 2022."

Answered by AI

What adverse effects can be associated with Aspiration Marker?

"The limited evidence for both safety and efficacy led to Aspiration Marker's score of 1 on a scale from 1-3."

Answered by AI

How large is the population participating in this experiment?

"Affirmative, clinicaltrials.gov points to this medical trial being open for participants as of November 8th 2022, with the initial posting occurring on December 1st 2015. This study is recruiting 20 individuals from a single research location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Validation of Aspiration Markers in Intubated Patients

Lorenzo Berra, MD 2015. "Validation of Aspiration Markers in Intubated Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02598713.