LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

NCT03571646 | Terminated Results FDA Device

• 1 other identifier: MDT17026
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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

Conditions

Respiratory Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate 2 Different Monitoring Devices

  72 hours

Study Arms (2)

Capnostream 20

OTHER

Continuous monitoring of CO2

Behavioral: Capnostream 20 monitoring

PM1000N-RR

OTHER

Continuous monitoring of SpO2

Device: PM1000N-RR monitoring

Interventions

Capnostream 20 monitoring BEHAVIORAL

Continuous monitoring on a general ward

Capnostream 20

PM1000N-RR monitoring DEVICE

Continuous monitoring on a general ward

PM1000N-RR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (2)

Universitätsklinikum Bonn

Bonn, D-53127, Germany

Location

Universitätsklinikum Gießen und Marburg

Marburg, 20043, Germany

Location

Results Point of Contact

• Title: Geraldine Kelly
• Organization: Medtronic

geraldine.kelly@medtronic.com

+353 879840223

Study Officials

• Andreas Hoeft, MDPhD

  Universitätsklinikum Bonn (AöR), D-53127 Bonn - Germany

  PRINCIPAL INVESTIGATOR

• Michael Sander, Dr.Med

  Universitätsklinikum Gießen und Marburg (UKGM) , 20043 Marburg - Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: During the study Phase I, the alarms of both devices will be silenced and the screen information blinded, as is the current clinical practice. During the study Phase II, the screen information will be available and the nursing staff will be instructed to respond to both devices' alarms based on a pre-defined hospital protocol.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 27, 2018
• Study Start: May 9, 2019
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: March 8, 2021
• Results First Posted: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)