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

NCT04017702 | Completed DMC FDA Device

• 1 other identifier: 2000021197
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative respiratory depression

  To define the incidence of postoperative respiratory depression between 2 devices.

  1 year

Secondary Outcomes (1)

• Detection of postoperative respiratory depression in high risk patients.

  1 year

Study Arms (3)

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

Interventions

Expiron respirator DEVICE

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.

Patients in step down/ICU.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group A; which will involve pregnant women with gestational age between 32-40 weeks. It will take place at: i. Labor and delivery floor/obstetric floor: 100 patients scheduled for cesarean section under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine. ii. Antenatal care: (obstetric floor, Long Wharf women clinic, Women center at Yale) Group B; in 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). Group C: in step down/ICU; 50 patients suffered from rib fracture and 50 patients after weaning from mechanical ventilation and extubation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06519-1362, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Aymen Alian, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: June 20, 2018
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

US (1)