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

Completed
Conditions
Respiratory Depression
Interventions
Device: Expiron respirator
Registration Number
NCT04017702
Lead Sponsor
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.

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
86
Inclusion Criteria
  • Patients who suffered rib fractures or patients who are weaned from mechanical ventilation and recently extubated.
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Exclusion Criteria
  • Have known contraindication/allergy to neuroaxial/paravertebral nerve block anesthesia
  • Patients allergic to morphine.
  • Have an ASA class > IV
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients in step down/ICU.Expiron respirator50 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.
Primary Outcome Measures
NameTimeMethod
The incidence of postoperative respiratory depression1 year

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

Secondary Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

Yale New Haven Hospital

🇺🇸

New Haven, Connecticut, United States

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