Prospective Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. Jul 18, 2019; 10(3): 57-66
Published online Jul 18, 2019. doi: 10.4292/wjgpt.v10.i3.57
Novel device for monitoring respiratory rate during endoscopy-A thermodynamic sensor
Vaibhav Wadhwa, Adalberto J Gonzalez, Kristen Selema, Ronen Feldman, Rocio Lopez, John J Vargo
Vaibhav Wadhwa, Adalberto J Gonzalez, Department of Gastroenterology and Hepatology, Cleveland Clinic Florida, Weston, FL 33324, United States
Kristen Selema, Department of Internal Medicine, Cleveland Clinic Florida, Weston, FL 33331, United States
Ronen Feldman, Department of Technology, Artep Incorporated, Elliot City, MD 21042, United States
Rocio Lopez, Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH 44195, United States
John J Vargo, Department of Gastroenterology and Hepatology, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH 44195, United States
Author contributions: Wadhwa V, Vargo JJ, and Feldman R designed the study; Lopez R analyzed the data; Wadhwa V, Gonzalez AJ, and Selema K wrote the paper; Vargo JJ revised the manuscript for final submission.
Institutional review board statement: The study was reviewed and approved by the Cleveland Clinic Foundation Institutional Review Board.
Clinical trial registration statement: The study did not undergo clinical trial registration, as the Institutional Review Board did not require it.
Informed consent statement: Informed consent was obtained from all the subjects that participated in this study.
Conflict-of-interest statement: Ronen Feldman has a financial interest in Linshom.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: John J Vargo, MD, MPH, Department of Gastroenterology and Hepatology, Digestive Disease and Surgery Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States.
Telephone: +1-216-4446521 Fax: +1-216-4446284
Received: February 3, 2019
Peer-review started: February 6, 2019
First decision: March 5, 2019
Revised: March 19, 2019
Accepted: April 8, 2019
Article in press: April 9, 2019
Published online: July 18, 2019
Research background

Monitoring ventilation appropriately during endoscopic procedures is a crucial yet challenging aspect of patient management and safety. Capnography is currently the standard of care for monitoring respiratory rate during endoscopy, but it is expensive and cumbersome to transfer. Furthermore, secretions, moisture, and carbon dioxide gas influence its results. The Linshom Respiratory Monitoring Device (LRMD) is a novel, non-invasive, and portable method for physicians to monitor respiratory activity during endoscopic procedures.

Research motivation

There is very limited data on how this novel and convenient method of monitoring respiratory rate, the LRMD, compares to the standard of care, capnography.

Research objectives

The main objective was to compare the effectiveness of apnea detection of the LRMD and capnography.

Research methods

A prospective study was performed. Twelve participants scheduled to undergo routine endoscopic procedures at Cleveland Clinic Main Campus were consecutively enrolled. All participants were individually fitted with a standard facemask fitted with both capnography and the LRMD. Data were collected from the medical record (gender, age, type of procedure, type of sedation, and dose of medication) and during the procedure (vital signs and body mass index). The data for the LRMD and capnography were collected simultaneously. A biomedical statistician conducted statistical analysis. The mean difference between the two devices was calculated. Pearson’s correlation was calculated to describe the correlation between the respiratory rate as calculated by the capnography and the LRMD.

Research results

Twelve patients were enrolled. Four were excluded due to technical difficulties. Data were gathered for approximately 3000 breaths over a total period of 190 min. The LRMD respiratory rate highly correlated with the capnography respiratory rate with a P value of < 0.001. LRMD and capnography had similar rates of detecting apnea.

Research conclusions

Our prospective study found that the respiratory rate measured by the LRMD highly correlates with the respiratory rate measured by capnography. The LRMD and capnography were also similar in detecting increases in respiratory rates and apnea episodes. This study demonstrates that the LRMD can be used in place of conventional capnography for monitoring respiratory status. This gives physicians an alternative to capnography that is new, efficient, easier to use, and more affordable. This reliable device can be an effective and safe alternative to monitoring ventilation in various settings.

Research perspectives

Our results show that the LRMD may be used as an alternative to capnography for measuring respiratory rate in the endoscopy setting and potentially in the post-anesthesia care, critical care, and other ambulatory settings. Further studies are needed to demonstrate the entire magnitude of LRMD capabilities, including the ability to monitor tidal volume. These studies should include the use of the LRMD in other settings.