LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

Medtronic

Status: Terminated

Conditions: Respiratory Complication

Treatments: Device: PM1000N-RR monitoring; Behavioral: Capnostream 20 monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT03571646

MDT17026

Details and patient eligibility

About

The purpose of this study is to document how often and how severe are the breathing difficulties that patients suffer, while recovering on a general ward following a serious operation

Full description

This is a prospective, 2-center, 2-phase pilot study of post-surgical adult patients on the hospital ward at high risk of developing respiratory and cardiovascular events. Phase I, 70 patients will be 1:1 randomly allocated to Capnostream 20p monitoring system or to PM1000N-RR pulse oximeter monitoring system and the alarms of both devices will be silenced and the screen information blinded, to establish a baseline for the incidence of respiratory events. Phase II, 140 patients will be 1:1 randomly allocated to Capnostream 20p or to PM1000N-RR monitoring but the screen information will be visible at the bedside and through the Vital Sync™ remote patient monitoring system.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-cardiac post-surgical patients at high risk of developing respiratory and cardiovascular events (High or intermediate risk for postoperative pulmonary complications).
• Adult age (≥18 year old).
• Patient is able and willing to give informed consent.

Exclusion criteria

• Expected ward length of stay ≤24 hours.
• Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
• Ventilated or intubated patients.
• Patient is unwilling or unable to comply fully with study procedures due to any disease condition which can raise doubt about compliance
• Patient is a member of a vulnerable population regardless of authorized representative support.
• Patient is participating in another potentially confounding drug or device clinical study.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Capnostream 20

Other group

Description:

Continuous monitoring of CO2

Treatment:

Behavioral: Capnostream 20 monitoring

PM1000N-RR

Other group

Description:

Continuous monitoring of SpO2

Treatment:

Device: PM1000N-RR monitoring