Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04017702
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 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 : June 20, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. The incidence of postoperative respiratory depression [ Time Frame: 1 year ]
    To define the incidence of postoperative respiratory depression between 2 devices.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Patients who suffered rib fractures or patienst 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Aymen Alian, MD 203-785-2802 aymen.alian@yale.edu
Contact: Karen Stavris, RN 203-785-3177 karen.stavris@yale.edu

Locations
Layout table for location information
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06519-1362
Contact: Karen Stavris, RN    203-785-3177    karen.stavris@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Layout table for investigator information
Principal Investigator: Aymen Alian, MD Yale University

Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04017702     History of Changes
Other Study ID Numbers: Alian_05.09.18
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Respiratory Insufficiency
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases