LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

Not Applicable

Terminated

Interventions: Behavioral: Capnostream 20 monitoring
Device: PM1000N-RR monitoring

Brief Summary: 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

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Capnostream 20	Capnostream 20 monitoring	Continuous monitoring of CO2
PM1000N-RR	PM1000N-RR monitoring	Continuous monitoring of SpO2

Primary Outcome Measures

Name	Time	Method
Quantify the Incidence and Severity of Post-operative Respiratory Compromise Markers	72 hours	Respiratory Compromise markers are identified by continuous monitoring to determine the benefit of continuous monitoring on the general ward

Secondary Outcome Measures

Name	Time	Method
Evaluate 2 Different Monitoring Devices	72 hours	Compare patient compliance and the sensitivity of two monitoring systems in high risk, post-surgical patients Study was stopped prematurely due to difficulties with enrollment and low participation rate. A decision was made not to analyze data as only 6 patients were enrolled which would not give meaningful results.