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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT04017702

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Depression	Device: Expiron respirator

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

Study Design

Study Type:

Observational

Actual Enrollment :

86 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 20, 2018

Actual Primary Completion Date :

Feb 20, 2020

Actual Study Completion Date :

Feb 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

The incidence of postoperative respiratory depression [1 year]
To define the incidence of postoperative respiratory depression between 2 devices.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Hospital	New Haven	Connecticut	United States	06519-1362

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Aymen Alian, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT04017702

Other Study ID Numbers:

2000021197

First Posted:

Jul 12, 2019

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Respiratory Insufficiency

Depression

Depressive Disorder

Study Results

No Results Posted as of Apr 1, 2022