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LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

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ClinicalTrials.gov Identifier: NCT03571646
Recruitment Status : Terminated (Poor recruitment rate due to difficulties in identifying suitable patients)
First Posted : June 27, 2018
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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

Condition or disease Intervention/treatment Phase
Respiratory Complication Behavioral: Capnostream 20 monitoring Device: PM1000N-RR monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Care Provider)
Masking Description: 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.
Primary Purpose: Screening
Official Title: LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward
Actual Study Start Date : May 9, 2019
Actual Primary Completion Date : December 14, 2019
Actual Study Completion Date : December 14, 2019

Arm Intervention/treatment
Capnostream 20
Continuous monitoring of CO2
Behavioral: Capnostream 20 monitoring
Continuous monitoring on a general ward

PM1000N-RR
Continuous monitoring of SpO2
Device: PM1000N-RR monitoring
Continuous monitoring on a general ward




Primary Outcome Measures :
  1. Quantify the incidence and severity of post-operative Respiratory Compromise markers [ Time Frame: 72 hours ]
    Respiratory Compromise markers are identified by continuous monitoring to determine the benefit of continuous monitoring on the general ward


Secondary Outcome Measures :
  1. Evaluate 2 different monitoring devices [ Time Frame: 72 hours ]
    Compare patient compliance and the sensitivity of two monitoring systems in high risk, post-surgical patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571646


Locations
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Germany
Universitätsklinikum Bonn
Bonn, Germany, D-53127
Universitätsklinikum Gießen und Marburg
Marburg, Germany, 20043
Sponsors and Collaborators
Medtronic - MITG
Investigators
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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
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03571646    
Other Study ID Numbers: MDT17026
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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