Respiratory ComplicationNCT03571646

LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

A study testing Capnostream 20 monitoring and PM1000N-RR monitoring in people with Respiratory Complication, run by Medtronic - MITG at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Complication
What is being tested?: Capnostream 20 monitoring and PM1000N-RR monitoring
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 2 sitesGermany
Study dates: 9 May 2019to 14 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Universitätsklinikum Bonn
Bonn, D-53127
Universitätsklinikum Gießen und Marburg
Marburg, 20043

Other trials in Germany

About this study

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

Read the 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.

Conditions: Respiratory Complication
Being tested: Capnostream 20 monitoring, PM1000N-RR monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Capnostream 20 monitoringBehavioural
Continuous monitoring on a general ward
PM1000N-RR monitoringDevice
Continuous monitoring on a general ward

Study groups in NCT03571646
Study group	Role	What they receive
Capnostream 20	Other	Continuous monitoring of CO2 Receives: Behavioral: Capnostream 20 monitoring
PM1000N-RR	Other	Continuous monitoring of SpO2 Receives: Device: PM1000N-RR monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 72 hours

Secondary outcomes (1)

Evaluate 2 Different Monitoring Devices
Compare patient compliance and the sensitivity of two monitoring systems in high risk, post-surgical patients Study was stopped prematurely due to difficulties with enrollment and low participation rate. A decision was made not to analyze data as only 6 patients were enrolled which would not give meaningful results.
Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 201914 Dec 2019

First posted27 Jun 2018
Study start9 May 2019
Primary completion14 Dec 2019
Study completion14 Dec 2019

Why it stopped: Poor recruitment rate due to difficulties in identifying suitable patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory ComplicationStudies of the same condition, open and under way.
More trials run by Medtronic - MITGThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Care provider
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03571646
Sponsor's protocol ID: MDT17026
Status last verified: Mar 2021
First submitted: 2 May 2018
Last updated: 8 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward
ClinicalTrials.gov ID: NCT03571646
Acronym / sponsor ID: MDT17026
Conditions: Respiratory Complication
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor recruitment rate due to difficulties in identifying suitable patients
Enrolment: 6 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: 9 May 2019 (actual)
Primary completion: 14 Dec 2019 (actual)
Study completion: 14 Dec 2019 (actual)
First posted: 27 Jun 2018 (actual)
Results: Posted 8 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2
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.

Arm	Type	Receives
Capnostream 20	Other	Behavioral: Capnostream 20 monitoringContinuous monitoring of CO2
PM1000N-RR	Other	Device: PM1000N-RR monitoringContinuous monitoring of SpO2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Capnostream 20 monitoringContinuous monitoring on a general ward	Behavioural	Capnostream 20
PM1000N-RR monitoringContinuous monitoring on a general ward	Device	PM1000N-RR

Primary outcome

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

1 secondary outcome

Evaluate 2 Different Monitoring Devices
Time frame: 72 hours

Results and safety

Results posted to the registry on 8 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Capnostream 20	3	1
PM1000N-RR	3	2

Primary outcome: Quantify the Incidence and Severity of Post-operative Respiratory Compromise Markers

Time frame: 72 hours

Population analysed: Study was stopped prematurely due to difficulties with enrollment and low participation rate. A decision was made not to analyze data as only 6 patients were enrolled which would not give meaningful results.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Capnostream 20	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
PM1000N-RR	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Respiratory Complication

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andreas Hoeft, MDPhD principal investigator

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

Michael Sander, Dr.Med principal investigator

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Capnostream 20 monitoring and PM1000N-RR monitoring in people with Respiratory Complication, run by Medtronic - MITG at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantify the Incidence and Severity of Post-operative Respiratory Compromise Markers (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03571646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.