LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

Respiratory Complication Clinical Trial

Official title:

LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03571646
• Other study ID #: MDT17026
• Status: Terminated
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: December 14, 2019

Study information

• Verified date: March 2021
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 14, 2019
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Respiratory Complication

Intervention

Behavioral:
• Capnostream 20 monitoring
Continuous monitoring on a general ward

Device:
• PM1000N-RR monitoring
Continuous monitoring on a general ward

Locations

Country	Name	City	State
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Gießen und Marburg	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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