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Completed

NCT Number: NCT04017702

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

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

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Key information

Conditions

Respiratory Depression Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06519-1362, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The incidence of postoperative respiratory depression

    Time frame: 1 year

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2019
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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