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

Study Overview

• Status: Terminated
• Conditions: Respiratory Complication
• Intervention / Treatment: Behavioral: Capnostream 20 monitoring; Device: PM1000N-RR monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, D-53127
    • Universitätsklinikum Bonn
  • Marburg, Germany, 20043
    • Universitätsklinikum Gießen und Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Andreas Hoeft, MDPhD, Universitätsklinikum Bonn (AöR), D-53127 Bonn - Germany; Principal Investigator: Michael Sander, Dr.Med, Universitätsklinikum Gießen und Marburg (UKGM) , 20043 Marburg - Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): December 14, 2019
• Study Completion (Actual): December 14, 2019

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MDT17026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes