LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

Study Overview
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Brief Summary
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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
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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.

Official Title
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LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

Conditions
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Respiratory Complication

Intervention / Treatment
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* Behavioral: Capnostream 20 monitoring
* Device: PM1000N-RR monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The occurrence of at least one of the following RC markers will be considered as primary endpoint for patients monitored by Capnostream 20p during both study Phases: (1) SpO2 ≤ 90% for ≥ 3 minutes.(2) RR ≤ 8 or ≥ 22 bpm for ≥ 3 minutes. (3) etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes. (4) Apnea episode lasting > 30 seconds. The occurrence of at least one of the following RC markers will be considered as primary endpoint for patients monitored by PM1000N-RR during both study Phases: (1) SpO2 ≤ 90% for ≥ 3 minutes. (2) RR ≤ 8 or ≥ 22 bpm for ≥ 3 minutes.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Capnostream 20<br>Continuous monitoring of CO2 | Behavioral: Capnostream 20 monitoring<br>* Continuous monitoring on a general ward<br>|
| Other: PM1000N-RR<br>Continuous monitoring of SpO2 | Device: PM1000N-RR monitoring<br>* Continuous monitoring on a general ward<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the Incidence and Severity of Post-operative Respiratory Compromise Markers | Respiratory Compromise markers are identified by continuous monitoring to determine the benefit of continuous monitoring on the general ward | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate 2 Different Monitoring Devices | 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. | 72 hours |