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LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward | Clinical Trials | Clareo Health

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LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

NCT03571646•Medtronic - MITG

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinikum Gießen und Marburg

Marburg, Germany

Key Dates

Start Date

May 9, 2019

Primary Completion Date

December 14, 2019

Completion Date

December 14, 2019

Last Updated

March 8, 2021

Enrollment

ACTUAL participants

Conditions

Respiratory Complication

Interventions

Capnostream 20 monitoring

BEHAVIORAL

PM1000N-RR monitoring

DEVICE

Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation

NCT06719258

Humidifier LungMechanical Fragility+1 more

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RECRUITING

Lung Ultrasound for Physiotherapy in Hospitalized Patients With Respiratory Complications

NCT06412081

Respiratory Complication

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

Inclusion Criteria

Exclusion Criteria

Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation

Lung Ultrasound for Physiotherapy in Hospitalized Patients With Respiratory Complications

Respiratory Trends During Blood Transfusions in Newborns.

Deflated and Inflated Cuff Endotracheal Extubations

Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia

Acute Effect of the Thoraco-abdominal Rebalance Method on Diaphragmatic Function, Respiratory Discomfort, Pulmonary Complications and Hemodynamic Variables in Postoperative Cardiac Surgery Patients