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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04017702

Enrollment

Registered

2019-07-12

Start date

2018-06-20

Completion date

2020-02-20

Last updated

2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Depression

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

Interventions

DEVICEExpiron 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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The incidence of postoperative respiratory depression	1 year	To define the incidence of postoperative respiratory depression between 2 devices.

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026