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

NCT01825278 | Completed

• 1 other identifier: IRB#10678
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Obstructive Sleep Apnea

Keywords

respiratory rate; tidal volume; minute ventilation; obese patients; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• ExSpiron monitor accurately reflects TV, MV and RR in obese patients in the preoperative holding area 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.

  1 - 1.5 hours before surgery

Secondary Outcomes (1)

• ExSpiron will accurately reflect the post-extubation respiratory status of the patient

  1 - 3 hours in the recovery room

Other Outcomes (1)

• apnea and hypopnea episodes in the recovery room detected by the ExSpiron monitor are correlated with the individual risk for obstructive sleep apnea

  1 - 3 hours postoperatively

Study Arms (1)

Single group, obese surgical patients with monitoring strip

All eligible patients will have a monitoring strip prospectively applied to their right chest

Device: ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA

Interventions

ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA DEVICE

Monitoring sensors will be applied to patient's right chest and the monitoring device will collect breathing parameters such as breathing rate and volumes before, during and after the procedure until patient is ready to leave the recovery room. At the beginning and at the end of the study investigator will perform a one-time measurement of patient's respiratory parameters using a standard handheld spirometer. This is a non-invasive device that is commonly used in clinical care not related to research.

Also known as: ExSpiron monitor

Single group, obese surgical patients with monitoring strip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese surgical patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Roman Schumann, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: April 5, 2013
• Study Start: February 1, 2013
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

US (1)