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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

Tracking Information
First Submitted Date  ICMJE May 2, 2018
First Posted Date  ICMJE June 27, 2018
Last Update Posted Date June 5, 2020
Actual Study Start Date  ICMJE May 9, 2019
Actual Primary Completion Date December 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward
Official Title  ICMJE LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Respiratory Complication
Intervention  ICMJE
  • Behavioral: Capnostream 20 monitoring
    Continuous monitoring on a general ward
  • Device: PM1000N-RR monitoring
    Continuous monitoring on a general ward
Study Arms  ICMJE
  • Capnostream 20
    Continuous monitoring of CO2
    Intervention: Behavioral: Capnostream 20 monitoring
  • PM1000N-RR
    Continuous monitoring of SpO2
    Intervention: Device: PM1000N-RR monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 3, 2020)
6
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2018)
300
Actual Study Completion Date  ICMJE December 14, 2019
Actual Primary Completion Date December 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03571646
Other Study ID Numbers  ICMJE MDT17026
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic - MITG
Study Sponsor  ICMJE Medtronic - MITG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic - MITG
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP