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NCT04017702 Clinical Trial

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

Respiratory Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04017702
Other study ID # 2000021197
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 20, 2018
Est. completion date February 20, 2020

Study information
Verified date March 2022
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 86
Est. completion date February 20, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Yale New Haven Hospital New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of postoperative respiratory depression To define the incidence of postoperative respiratory depression between 2 devices. 1 year
Secondary Detection of postoperative respiratory depression in high risk patients. To determine the agreement between these 2 devices in detection of postoperative respiratory depression in high risk patients. 1 year
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