ObesityNCT01825278
Evaluation of a Respiratory Monitor in Surgical Patients With a BMI>35
An observational study of Obesity and Obstructive Sleep Apnea, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obstructive Sleep Apnea
- What is being tested?
- ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese surgical patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity, Obstructive Sleep Apnea
- Being tested
- ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA
- Keywords
- respiratory rate, tidal volume, minute ventilation, obese patients, obstructive sleep apnea
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MADevice
Also called ExSpiron monitor
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.
| Study group | Role | What they receive |
|---|---|---|
| Single group, obese surgical patients with monitoring strip | All eligible patients will have a monitoring strip prospectively applied to their right chest Receives: Device: ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 - 1.5 hours before surgery
Secondary outcomes (1)
ExSpiron will accurately reflect the post-extubation respiratory status of the patient
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
Measured: 1 - 3 hours in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman Schumann, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825278
- Sponsor's protocol ID
- IRB#10678
- Status last verified
- May 2024
- First submitted
- 22 Mar 2013
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Respiratory Monitor in Surgical Patients With a BMI >35 Undergoing Elective Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01825278
- Acronym / sponsor ID
- IRB#10678
- Conditions
- Obesity, Obstructive Sleep Apnea
- Keywords
- respiratory rate, tidal volume, minute ventilation, obese patients, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group, obese surgical patients with monitoring strip | – | Device: ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MAAll eligible patients will have a monitoring strip prospectively applied to their right chest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese surgical patients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MAAlso: ExSpiron monitorMonitoring 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. | Device | Single group, obese surgical patients with monitoring strip |
Primary outcome
ExSpiron monitor accurately reflects TV, MV and RR in obese patients in the preoperative holding area before surgery
Time frame: 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.
1 secondary outcome
ExSpiron will accurately reflect the post-extubation respiratory status of the patient
Time frame: 1 - 3 hours in the recovery room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Schumann, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obstructive Sleep Apnea, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ExSpiron monitor accurately reflects TV, MV and RR in obese patients in the preoperative holding area before surgery (time frame: 1 - 1.5 hours before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.