Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring
- Conditions
- Respiratory Depression
- Interventions
- Device: Expiron respirator
- Registration Number
- NCT04017702
- Lead Sponsor
- Yale University
- Brief Summary
Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in detection of postoperative respiratory depression in high risk patients.
- Detailed Description
Aims are to: 1) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous pulse oximetry 2) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous respiratory volume monitor (RVM) (ExSpiron) 3) Assess the agreement between the continuous pulse oximetry and continuous respiratory volume monitor (RVM) (ExSpiron) in detection of postoperative respiratory depression in high risk patients
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Patients who suffered rib fractures or patients who are weaned from mechanical ventilation and recently extubated.
- Have known contraindication/allergy to neuroaxial/paravertebral nerve block anesthesia
- Patients allergic to morphine.
- Have an ASA class > IV
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients in step down/ICU. Expiron respirator 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.
- Primary Outcome Measures
Name Time Method The incidence of postoperative respiratory depression 1 year To define the incidence of postoperative respiratory depression between 2 devices.
- Secondary Outcome Measures
Name Time Method Detection of postoperative respiratory depression in high risk patients. 1 year To determine the agreement between these 2 devices in detection of postoperative respiratory depression in high risk patients.
Trial Locations
- Locations (1)
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States