Clinical trial NCT03571646: LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward
Official title: LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Complication
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2018-06-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quantify the Incidence and Severity of Post-operative Respiratory Compromise Markers
timeFrame: 72 hours
Secondary outcomes:
measure: Evaluate 2 Different Monitoring Devices
timeFrame: 72 hours
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg
Study officials:
affiliation: Universitätsklinikum Bonn (AöR), D-53127 Bonn - Germany
name: Andreas Hoeft, MDPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Gießen und Marburg (UKGM) , 20043 Marburg - Germany
name: Michael Sander, Dr.Med
role: PRINCIPAL_INVESTIGATOR
References: