Evaluation of a Respiratory Monitor in Surgical Patients With a BMI>35

Completed

• Conditions: Obstructive Sleep Apnea; Obesity
• Interventions: Device: ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA

• Registration Number: NCT01825278
• Lead Sponsor: Tufts Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-05
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group, obese surgical patients with monitoring strip	ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA	All eligible patients will have a monitoring strip prospectively applied to their right chest

Primary Outcome Measures

Name	Time	Method
ExSpiron monitor accurately reflects TV, MV and RR in obese patients in the preoperative holding area before surgery	1 - 1.5 hours before surgery	Patient will have a monitoring strip applied to right chest in the pre op holding area, and respiratory data will be recorded to the monitor. These will be compared with data from a manual handheld spirometer via 5 recordings over a time period of 5 minutes.

Secondary Outcome Measures

Name	Time	Method
ExSpiron will accurately reflect the post-extubation respiratory status of the patient	1 - 3 hours in the recovery room	Patient will continue to be monitored for MV, TV and RR after surgery in the recovery room, until recovery from anesthesia up to 3 hours. Respiratory data will be recorded to the monitor. These will be compared with data from a manual handheld spirometer via 3 recordings over a time period of 3 minutes. The change in the respiratory values to preoperative baseline will also be compared

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States