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Leak-free Bronchoscope Adapter for Respiratory Insufficiency

N/A

Waitlist Available

Led By Beth Hochman, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at one minute into the procedure

Awards & highlights

Study Summary

This trial will compare the standard, commercially available bronchoscope adapter to a new, "leak-free" adapter in order to determine if the new adapter is more effective in limiting air leakage during the bronchoscopy procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at one minute post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at one minute post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at one minute post-procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from baseline of Particulate matter (PM) in air immediately post-procedure

Change from baseline of Pulmonary dynamic compliance immediately post-procedure

Change from baseline of aerosolized pathogens immediately post-procedure

+2 more

Secondary outcome measures

Change from baseline of Heart rate during procedure

Change from baseline of systolic and diastolic blood pressure during procedure

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Leak-free bronchoscope adapterExperimental Treatment1 Intervention

The mechanical ventilation circuit used in patients with respiratory failure is considered a closed-loop circuit between the patient and the ventilator. This allows air to flow from the ventilator to the patient and back to the circuit without escaping to the ambient environment. To perform bronchoscopy, a standard adapter is spliced into the ventilator circuit, which allows the bronchoscope to enter the ventilation circuit granting access to the patient's airways. This study will compare the efficacy of the standard commercially available adapter to the newly developed leak-free adapter. The intervention is considered the "leak-free bronchoscope adapter."

Group II: Standard bronchoscope adapterActive Control1 Intervention

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Find a Location

Who is running the clinical trial?

State University of New York - Downstate Medical CenterOTHER

66 Previous Clinical Trials

12,599 Total Patients Enrolled

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,461,015 Total Patients Enrolled

6 Trials studying Respiratory Insufficiency

1,509 Patients Enrolled for Respiratory Insufficiency

Beth Hochman, MDPrincipal InvestigatorColumbia University

Frequently Asked Questions

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

Are individuals currently being recruited to participate in this research?

"Affirmative. According to the clinicaltrials.gov information, this study is currently recruiting individuals for participation. It was first made available on September 15th 2022 and its most recent update occurred on August 5th 2022. This medical trial requires 20 volunteers at a single site in order to be successful."

Answered by AI

How many participants have enrolled in this investigation so far?

"That is accurate. Clinicaltrials.gov provides evidence that this medical trail, which was established on September 15th 2022, is currently recruiting volunteers. 20 participants need to be sourced from 1 centre of care."

Answered by AI

Recent research and studies

Critical Care MedicineJournal

ICU Occupancy and Mechanical Ventilator Use in the United States*

Wunsch, Hannah, Jason Wagner, Maximilian Herlim, David H. Chong, Andrew A. Kramer, and Scott D. Halpern. 2013. “ICU Occupancy and Mechanical Ventilator Use in the United States*”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ccm.0b013e318298a139.

Critical CareJournal

Ventilator-associated Pneumonia in the ICU

Kalanuria, Atul, Wendy Zai, and Marek Mirski. 2014. “Ventilator-associated Pneumonia in the ICU”. Critical Care. Springer Science and Business Media LLC. doi:10.1186/cc13775.

PLoS ONEJournal

Aerosol Generating Procedures and Risk of Transmission of Acute Respiratory Infections to Healthcare Workers: A Systematic Review

Tran, Khai, Karen Cimon, Melissa Severn, Carmem L. Pessoa-Silva, and John Conly. 2012. “Aerosol Generating Procedures and Risk of Transmission of Acute Respiratory Infections to Healthcare Workers: A Systematic Review”. Edited by Malcolm Gracie Semple. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0035797.

The LancetJournal