Evaluation of Leak-free Bronchoscope Adapter

NCT05288218 | Withdrawn FDA Device

• 1 other identifier: AAAT3916
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients who develop respiratory failure require the assistance of mechanical ventilation while recovering from their respiratory injury. For example, patients that are affected by COVID-19 can develop such severe respiratory failure that they are unable to breathe on their own and therefore require the assistance of a mechanical ventilator. A Bronchoscope is a tool that can be used to visualize the inside of the lungs to aid in further diagnosis and delivery of therapeutic agents in patients with respiratory disease or failure. However, bronchoscopy can cause air to leak from the patient's lungs into the room due to a poorly designed adapter that is required to facilitate the introduction of the bronchoscope into the lungs. This leak can lead to the patient losing oxygen during the procedure which can be harmful to the patient and delay or limit recovery. Additionally, the air that leaks can lead to the spread of bacteria/viruses into the ambient air, which can contaminate the intensive care unit and expose other patients and healthcare workers to harmful pathogens. This was highlighted most recently during the COVID-19 pandemic where national guidelines limited the use of bronchoscopy in patients affected by the virus due to concerns about spreading the virus within the hospital and to the healthcare workers. In this study, the investigators will evaluate the efficacy of a novel adapter that avoids air leakage during bronchoscopy. Patients with respiratory failure on mechanical ventilation who require bronchoscopy will be randomized into two groups (groups A and B). These patients will be identified by the intensive care unit physician. Informed consent will be obtained from the patient's health care proxy. Patients in group A will undergo bronchoscopy using the standard commercially available adapter. Patients in group B will undergo bronchoscopy using the newly developed bronchoscope adapter. The efficacy of the bronchoscopy adapter will be evaluated by analyzing ventilator-associated parameters as well as the level of air contamination after the procedure. A bronchoscope adapter that limits air leak would have significant value in improving patient outcomes who receive bronchoscopy. Additionally, this would allow bronchoscopy to be more readily performed in patients with potential bacterial/viral pathogen spread. Primary objective: Determination of equivalency or superiority of the new "leak-free adapter" compared to the standard commercial adapter to enable safe bronchoscopy in ventilated patients requiring bronchoscopy. Secondary objective: To determine if the adapter provides improved ventilation during bronchoscopy by limiting tidal volume loss and pathogen aerosolization.

Conditions

Respiratory Insufficiency

Keywords

bronchoscopy; mechanical ventilation; hypoxemia; covid-19; pathogen spread

Outcome Measures

Primary Outcomes (5)

• Change from baseline of tidal volume loss during procedure

  To measure tidal volume loss, the patient's ventilator displays both total volume of inspired (VTi) air and expired (VTe) air for each breath given. Immediately prior to the start of bronchoscopy, baseline values for VTi and VTe will be recorded for 10 breaths. Upon initiation of bronchoscopy, the VTi and VTe values will be recorded for 10 breaths one minute after the initiation of the bronchoscopy procedure.

  Baseline and at one minute into the procedure

• Change from baseline of oxygen saturation levels during procedure

  To measure patient oxygen saturation (SpO2) as measured using a pulse oximeter through the procedure. Immediately prior to bronchoscopy, the patient's baseline circulating oxygen saturation will be recorded during 10 ventilated breaths. One minute after initiation of bronchoscopy, the SpO2 level will be recorded for 10 breaths during the procedure. The oxygen saturation sensor is a standard non-invasive device placed on the patient and provides continuous pulse oximetry monitoring.

  Baseline and at one minute into the procedure

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

  Air quality samples will be obtained to monitor the level and degree of circulating particulate matter using an air quality sampler. The sampling device will obtain an air sample immediately before the bronchoscopic procedure as baseline, and a second sample will be obtained immediately after the procedure. The sampling device is a non-invasive tool placed within the room and near the participant during the procedure.

  Baseline and at one minute post-procedure

• Change from baseline of aerosolized pathogens immediately post-procedure

  Air quality samples will be obtained to monitor the level and degree of aerosolized pathogens using an air quality sampler. The sampling device will obtain an air sample immediately before the bronchoscopic procedure as baseline, and a second sample will be obtained immediately following the procedure. The sampling device is a non-invasive tool placed within the room and near the participant during the procedure.

  Baseline and at one minute post-procedure

• Change from baseline of Pulmonary dynamic compliance immediately post-procedure

  Immediately prior to initiating the bronchoscopic procedure, a baseline pulmonary dynamic compliance value will be obtained from the ventilator. The ventilator provides this continuous value in all intubated patients. A repeat value will then be obtained immediately following the completion of the bronchoscopic procedure.

  Baseline and at one minute post-procedure

Secondary Outcomes (2)

• Change from baseline of Heart rate during procedure

  Baseline and at one minute into the procedure

• Change from baseline of systolic and diastolic blood pressure during procedure

  Baseline and at one minute into the procedure

Study Arms (2)

Leak-free bronchoscope adapter

EXPERIMENTAL

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."

Device: Leak-free Bronchoscope Adapter

Standard bronchoscope adapter

ACTIVE COMPARATOR

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. This arm utilizes the standard adapter.

Device: Standard Bronchoscope Adapter

Interventions

Leak-free Bronchoscope Adapter DEVICE

A novel leak-free bronchoscope adapter will connect to the ventilation circuit in place of a standard adapter.

Leak-free bronchoscope adapter

Standard Bronchoscope Adapter DEVICE

Commercially available bronchoscope adapter (Smiths Medical)

Standard bronchoscope adapter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Male or female
• Aged 18 years or above
• The participant may not enter the study if ANY of the following apply:
• Female participants who are pregnant during the study.
• SpO2 (oxygen saturation) \< 90% at baseline.
• The patient requires high ventilation requirements as indicated by a positive end-expiratory pressure (PEEP) greater than 20 mmHg or inspired oxygen requirements greater than 90%.
• Hemodynamic instability requiring significant use of vasoactive pressors to maintain blood pressure.
• Any other significant disease or disorder that, in the Investigator's opinion, may either put the participants at risk because of participation in the study or may influence the result of the study.

Sponsors & Collaborators

• Columbia University: lead
• State University of New York - Downstate Medical Center: collaborator

Related Publications (5)

• Wunsch H, Wagner J, Herlim M, Chong DH, Kramer AA, Halpern SD. ICU occupancy and mechanical ventilator use in the United States. Crit Care Med. 2013 Dec;41(12):2712-9. doi: 10.1097/CCM.0b013e318298a139.

  PMID: 23963122 BACKGROUND

• Cummings MJ, Baldwin MR, Abrams D, Jacobson SD, Meyer BJ, Balough EM, Aaron JG, Claassen J, Rabbani LE, Hastie J, Hochman BR, Salazar-Schicchi J, Yip NH, Brodie D, O'Donnell MR. Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study. Lancet. 2020 Jun 6;395(10239):1763-1770. doi: 10.1016/S0140-6736(20)31189-2. Epub 2020 May 19.

  PMID: 32442528 BACKGROUND

• Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. No abstract available.

  PMID: 25029020 BACKGROUND

• Chhajed PN, Glanville AR. Management of hypoxemia during flexible bronchoscopy. Clin Chest Med. 2003 Sep;24(3):511-6. doi: 10.1016/s0272-5231(03)00050-9.

  PMID: 14535223 BACKGROUND

• Tran K, Cimon K, Severn M, Pessoa-Silva CL, Conly J. Aerosol generating procedures and risk of transmission of acute respiratory infections to healthcare workers: a systematic review. PLoS One. 2012;7(4):e35797. doi: 10.1371/journal.pone.0035797. Epub 2012 Apr 26.

  PMID: 22563403 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia; COVID-19

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Beth Hochman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery (in Anesthesiology), Dept of Surgery Acute Care

Model Details: 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." The study will be conducted as a randomized control trial in patients who require bronchoscopy. Once the participant has been randomized to either the "leak free adapter" vs. "standard adapter" group, the bronchoscope adapter will be spliced into the ventilator circuit. Bronchoscopy will then be performed by the primary critical care physician in the intensive care unit.

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: March 21, 2022
• Study Start: May 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share