Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring
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|ClinicalTrials.gov Identifier: NCT04017702|
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment|
|Respiratory Depression||Device: Expiron respirator|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring|
|Actual Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Pregnant women with gestational age between 32-40 weeks.
100 patients scheduled for cesarean section under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine.
Patients post anesthesia care units (PACU) and surgical floor.
100 patients scheduled to receive General Anesthesia (GA) and planned to receive opioid intravenously (boluses/patient controlled analgesia (PCA).
Patients in step down/ICU.
50 patients suffered from rib fracture and 50 patients after weaning from mechanical ventilation and extubation.The Expiron will provide continuous information about the respiratory status (tidal volume, respiratory rate and minute ventilation) of non-intubated patients specifically: sleeping or awake; with the use of incentive spirometry; the response to medications and other interventions (such as paravertebral/epidural block); the need for endotracheal re-intubation.
Device: Expiron respirator
Respiratory volume monitor (RVM) (ExSpiron, is a non-invasive FDA approved device that monitors minute ventilation (MV) and provides an early indication of respiratory status in non-intubated patients. The system consists of a lightweight monitor, a patient cable, and a disposable electrode PadSet, which detects changes in breathing.
- The incidence of postoperative respiratory depression [ Time Frame: 1 year ]To define the incidence of postoperative respiratory depression between 2 devices.
- Detection of postoperative respiratory depression in high risk patients. [ Time Frame: 1 year ]To determine the agreement between these 2 devices in detection of postoperative respiratory depression in high risk patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017702
|Contact: Aymen Alian, MDfirstname.lastname@example.org|
|Contact: Karen Stavris, RNemail@example.com|
|United States, Connecticut|
|Yale New Haven Hospital||Recruiting|
|New Haven, Connecticut, United States, 06519-1362|
|Contact: Karen Stavris, RN 203-785-3177 firstname.lastname@example.org|
|Principal Investigator:||Aymen Alian, MD||Yale University|