Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02295306 |
| Other study ID # |
IRB # 10880 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2013 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Tufts Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Sleep disordered breathing; specifically obstructive sleep apnea (OSA) is a disease affecting
8-12% of the general population and often more than 70% of the bariatric surgical population.
OSA is characterized by the repetitive collapse of the upper airway, causing a reduction or
cessation in airflow and decreases in oxygen saturation. These events are resolved by
arousals from sleep, reducing sleep quality and leading to excessive daytime sleepiness. An
in-laboratory polysomnography (PSG) is the gold standard for the diagnosis of OSA.
Previous studies have established obstructive sleep apnea (OSA) as a potential independent
risk factor for postoperative complications, adverse surgical outcomes, and longer hospital
stays.
Patients with OSA have an increase in postoperative complications, the most frequent being
oxygen desaturation, postoperative atelectasis and increased postoperative pain. Despite the
clear risks, OSA remains under diagnosed with an estimated 25-30% of patients at a high risk
for OSA. It has been suggested that OSA events may be even more frequent post operatively
because of the residual effects of anesthesia and the use of potent pain medications such as
opioids. Postoperatively apneas often go undetected and untreated. The use of supplemental O2
may mask any desaturations and there is no convenient technology to noninvasively monitor
ventilation to detect apnea and hypopnea in post-surgical patients.
New advances in technology and digital signal processing have led to the development of an
impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion,
Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive
measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR). Our
main hypotheses are that the non-invasive, impedance-based RVM monitor will accurately
reflect TV, RR and MV during sleep and will detect apneas and hypopneas accurately.
Description:
This is an observational pilot study to evaluate the clinical applicability of the ExSpiron
Respiratory Volume Monitor (RVM) in patients with suspected sleep apnea. Previous work has
demonstrated the ability of the RVM to provide non-invasive, real-time, continuous
measurements of respiratory parameters (MV, TV, and RR) but those studies have not
specifically looked at patients during sleep or patients with sleep disordered breathing.
Previously there was no device capable of providing, continuous, non-invasive, real time
measurements of ventilatory status such as minute ventilation, tidal volume and RR. The
ExSpiron system utilizing impedance based technology and proprietary algorithms (Respiratory
Motion Inc., Waltham, MA) have been developed to obtain these measurements.
Respiratory Motion, Inc. has previously evaluated ExSpiron measurements of respiratory
parameters (MV, TV and RR) in studies of adult volunteer subjects. Stimulus leads delivered
an alternating minimal current (1.5 mA) at a frequency of 50 kHz and recording leads recorded
differential voltages to calculate impedance. Subject data (height, weight, age, gender,
chest circumference) were measured. The studies showed that using the optimal lead placement
configuration, algorithms based on chest wall impedance and respiratory pattern analysis
provided provided RVM measurements and ExSpiron curves which correlated strongly with
spirometry volumes and spirometry curves.
A large percentage of patients in the general surgical population have undiagnosed OSA. This
population is at increased risk of adverse perioperative respiratory complications.
Assessment and management of perioperative respiratory function and early intervention when
indicated is a multifaceted, complex task often complicated by the unavailability of an
accurate and continuous monitoring system that can demonstrate apnea and hypopnea to guide
clinical decision making. The ExSpiron system is designed for these patients and is intended
to address some of the limitations of the current generation of hospital monitors as listed
below:
In the, non-ventilated patient, current monitoring devices do not provide objective
non-invasive, continuous real time measurements of important respiratory parameters MV, TV
and RR that reflect respiratory competence, nor do they provide adequate assessment of apnea
and hypopnea.
Current monitoring of non-intubated patients mostly relies on oximetry data, subjective
clinical assessment which measures respiration and not ventilation and rarely transcutaneous
CO2 measurements. In appropriate clinical settings, the ExSpiron system can provide direct
quantitative measure of ventilation (MV, TV and RR) that can be used in the detection of
apnea and hypopnea.
Precise apnea and hypopnea assessment.
Most if not all of the gaps left by current respiratory assessment technologies may be filled
by a non-invasive monitor such as the one proposed for use in this study. There are many
potential applications for this technology including: use in peri-procedural environment to
evaluate the effects of medication on ventilation and detection of apnea/hypopnea. In
addition, it may be useful in clinical decision making regarding medication adjustments of
pain management protocols, evaluation ventilatory status prior to extubation and evaluation
of the need for reintubation, but also trending of respiratory patterns to avoid risky
emergency airway management interventions.
New advances in technology and digital signal processing have led to the development of an
impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion,
Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive
measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR). Our
main hypotheses are that the non-invasive, impedance-based RVM monitor will accurately
reflect TV, RR and MV during sleep and will detect apneas and hypopneas accurately.
Main Hypothesis: The ExSpiron monitor accurately reflects apnea and hypopnea events compared
to standard polysomnography. The ExSpiron monitor is able to distinguish between central and
obstructive apneic events.
Secondary Hypothesis: 1) Correlation of MV% as compared to % predicted with comorbidities
(e.g. hypertension and metabolic syndrome), 2)Correlation of MV changes as compared to MV%
predicted with oxygen desaturation index (ODI), 3) evaluation breathing patterns before and
after obstruction, 4) evaluation of breathing patterns in different types of apnea (central,
obstructive and mixed).
