Evaluation of a Respiratory Monitor in Surgical Patients With a BMI>35
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Obesity Weight Loss, Pulmonary |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | February 2013 |
| End Date: | December 2019 |
The Evaluation of a Respiratory Monitor in Surgical Patients With a BMI >35 Undergoing Elective Surgery Under General Anesthesia
This study proposes to evaluate the clinical applicability of the ExSpiron Respiratory Volume
Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) in obese surgical patients
undergoing general anesthesia. Previous work has demonstrated the ability of the ExSpiron
monitor to provide non-invasive, real-time, continuous measurements of respiratory parameters
such as tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in normal
weight patients but those studies did not specifically look at obese subjects. Respiratory
depression, in the postoperative setting due to residual anesthetics and/or opioid
administration, continues to be a significant cause of adverse outcomes. Obese patients are
at increased risk for respiratory complications. Currently, there is no objective measure of
early respiratory indicators for developing respiratory compromise. 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. There is no current device capable of giving
real time ventilatory information such as tidal volume and minute ventilation of a patient
that is not mechanically ventilated. The ExSpiron system utilizes an impedance based
technology and proprietary algorithms (Respiratory Motion Inc.) to obtain these measurements.
The study hypotheses are that the non-invasive, impedance-based RVM monitor will accurately
reflect TV, RR and MV in obese surgical patients before induction of general anesthesia,
during controlled ventilation and following extubation; that ExSpiron will accurately reflect
the post-extubation respiratory status of the patient; and that apnea and hypopnea episodes
in the recovery room as detected by the ExSpiron monitor are correlated with the individual
risk for obstructive sleep apnea as determined by the STOP-Bang risk stratification.
Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) in obese surgical patients
undergoing general anesthesia. Previous work has demonstrated the ability of the ExSpiron
monitor to provide non-invasive, real-time, continuous measurements of respiratory parameters
such as tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in normal
weight patients but those studies did not specifically look at obese subjects. Respiratory
depression, in the postoperative setting due to residual anesthetics and/or opioid
administration, continues to be a significant cause of adverse outcomes. Obese patients are
at increased risk for respiratory complications. Currently, there is no objective measure of
early respiratory indicators for developing respiratory compromise. 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. There is no current device capable of giving
real time ventilatory information such as tidal volume and minute ventilation of a patient
that is not mechanically ventilated. The ExSpiron system utilizes an impedance based
technology and proprietary algorithms (Respiratory Motion Inc.) to obtain these measurements.
The study hypotheses are that the non-invasive, impedance-based RVM monitor will accurately
reflect TV, RR and MV in obese surgical patients before induction of general anesthesia,
during controlled ventilation and following extubation; that ExSpiron will accurately reflect
the post-extubation respiratory status of the patient; and that apnea and hypopnea episodes
in the recovery room as detected by the ExSpiron monitor are correlated with the individual
risk for obstructive sleep apnea as determined by the STOP-Bang risk stratification.
Inclusion Criteria:
- ASA 1 - 3 patients with a body mass index (BMI) ≥ 35kg/m2 presenting for elective
surgery under general anesthesia aged > 18 years. Ability to provide written informed
consent.
Exclusion Criteria:
- Emergent surgical patients, patients with a BMI < 35kg/m2, patients not competent to
give informed consent, pregnant patients (women of child bearing potential who want to
participate will have a pregnancy test done prior to enrollment in the study),
patients with implantable electronic devices (pacemakers, stimulators, etc.);
predictable interference with surgical procedure or standard of care.
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