Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring

Yale University

Status: Completed

Conditions: Respiratory Depression

Treatments: Device: Expiron respirator

Study type: Observational

Funder types: Other

Identifiers

NCT04017702

2000021197

Details and patient eligibility

About

Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in detection of postoperative respiratory depression in high risk patients.

Full 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

Enrollment: 86 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who suffered rib fractures or patients who are weaned from mechanical ventilation and recently extubated.

Exclusion criteria

• Have known contraindication/allergy to neuroaxial/paravertebral nerve block anesthesia
• Patients allergic to morphine.
• Have an ASA class > IV

Trial design

86 participants in 3 patient groups

Pregnant women with gestational age between 32-40 weeks.

Description:

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.

Description:

100 patients scheduled to receive General Anesthesia (GA) and planned to receive opioid intravenously (boluses/patient controlled analgesia (PCA).

Patients in step down/ICU.

Description:

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.

Treatment:

Device: Expiron respirator