Monitoring for Low Minute Ventilation Post Surgery Clinical Trial
Official title:
Blinded Observational Study to Evaluate a Non-Invasive Respiratory Volume Monitor in the Post-Anesthesia Care Unit and on the General Hospital Floor
This observational study investigates the validity and utility of a new, non-significant risk, FDA approved respiratory monitor, ExSpiron, in the perioperative course of patients undergoing elective surgery under general anesthesia. The study patients will be monitored before, during and after surgery, in post-anaesthesia care unit (PACU) and recovery room for the first post-operative night. The physiologic data will not be used or influence the standard of care for subjects. It is anticipated that this monitor may be able to improve perioperative care in the future.
Aim and Hypotheses Currently, there is no objective measure of early respiratory indicators
for developing respiratory compromise in surgical patients. Current respiratory assessment in
non-intubated patients relies on oximetry data and subjective clinical assessment. Pulse
oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late
indicator of respiratory decline. 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) in general patient population.
Hypotheses
Primary:
Low minute ventilation (LMV) defined as sustained LMV<40% minute ventilation predicted
(MVPRED) based on IBW following opioid administration correlates with adverse clinical
outcomes in PACU or on the floor including:
- O2 desaturation, atelectasis, respiratory status requiring advanced monitoring
- respiratory interventions such as O2 administration, continuous positive airway pressure
CPAP, BiPAP,
- incidence of ICU transfer and/or increase in PACU and/or general hospital floor (GHF)
length of stay (LOS).
Secondary:
- 1. Decreased MV defined as sustained MV<80% MVPRED based on IBW before opioid
administration correlates with adverse clinical outcomes as defined above.
- 2. Patients with decreased MV prior to opioid administration will be more likely to
develop LMV after standard opioid administration compared to patients with normal MV
defined as MV ≥ 81% MVPRED based on ideal body weight (IBW)
Rationale Continuous respiratory monitoring using the ExSpiron System will be particularly
beneficial to patients in the post-anesthesia environment. Assessment and management of
respiratory function and early intervention when indicated is a multifaceted, complex task
often complicated by the lack of a cohesive and continuous monitoring system to guide
clinical decisions. The ExSpiron system is designed for these patients and is intended to
address some of the limitations of the current generation of hospital monitors and to provide
healthcare providers with continuous real-time data regarding the patient's respiratory
status. Recent data has shown that stratification of patients based on the RVM's MV as % of
predicted MV (MVPRED), prior to opioid dosing has made it possible to identify patients who
are at risk for further decreases in MV and opioid-induced respiratory depression (OIRD).
1. In the spontaneously breathing, non-ventilated patient, current monitoring devices do
not provide continuous, objective non-invasive, continuous real time information of the
important respiratory parameters TV, MV & RR.
2. Current monitoring of non-intubated patients mostly relies on subjective clinical
assessment, oximetry data, and rarely end-tidal carbon dioxide CO2 measurements. In
appropriate clinical settings, the ExSpiron system can provide direct quantitative
measure of ventilation parameters for use in clinical assessment and trend prediction as
well as response to medications and other interventions to allow for more efficient
clinical decision making.
3. Current technologies do not provide for a continuity of care between the PACU and the
general hospital floor.
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