LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

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

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.

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.