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NCT01825278 · ClinicalTrials.gov registry record
Evaluation of a Respiratory Monitor in Surgical Patients With a BMI>35
A clinical trial, sponsored by Tufts Medical Center.
- Completed
- Registry status
- 90
- Enrollment target
NCT01825278 is a clinical trial that has completed, run by Tufts Medical Center. The registered enrollment target is 90 participants.
The verdict
NCT01825278 has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- 90 participants
- Enrollment target
Study 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.
Interventions
- DEVICE ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2013-02 |
| Est. Completion | 2024-04-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01825278
The ClinicalTrials.gov registry entry for NCT01825278 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA is the first listed.
NCT01825278 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01825278 about?
NCT01825278 is a clinical study titled "Evaluation of a Respiratory Monitor in Surgical Patients With a BMI>35". 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-in...
What is the current status of trial NCT01825278?
This trial is currently completed. The enrollment target is 90 participants. The study started on 2013-02. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT01825278?
The interventions under investigation include: ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA (DEVICE).
Who is sponsoring clinical trial NCT01825278?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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