Trial Outcomes & Findings for LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward (NCT NCT03571646)

Last Updated: 2021-03-08

Results Overview

Respiratory Compromise markers are identified by continuous monitoring to determine the benefit of continuous monitoring on the general ward

Recruitment status

TERMINATED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

72 hours

Results posted on

2021-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Capnostream 20 Continuous monitoring of CO2 Capnostream 20 monitoring: Continuous monitoring on a general ward	PM1000N-RR Continuous monitoring of SpO2 PM1000N-RR monitoring: Continuous monitoring on a general ward
Overall Study STARTED	3	3
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Capnostream 20 Continuous monitoring of CO2 Capnostream 20 monitoring: Continuous monitoring on a general ward	PM1000N-RR Continuous monitoring of SpO2 PM1000N-RR monitoring: Continuous monitoring on a general ward
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capnostream 20 n=3 Participants Continuous monitoring of CO2 Capnostream 20 monitoring: Continuous monitoring on a general ward	PM1000N-RR n=3 Participants Continuous monitoring of SpO2 PM1000N-RR monitoring: Continuous monitoring on a general ward	Total n=6 Participants Total of all reporting groups
Age, Customized	NA years STANDARD_DEVIATION NA • n=3 Participants	NA years STANDARD_DEVIATION NA • n=3 Participants	NA years STANDARD_DEVIATION NA • n=6 Participants
Sex: Female, Male Female	NA Participants n=3 Participants	NA Participants n=3 Participants	NA Participants n=6 Participants
Sex: Female, Male Male	NA Participants n=3 Participants	NA Participants n=3 Participants	NA Participants n=6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	NA Participants n=3 Participants	NA Participants n=3 Participants	NA Participants n=6 Participants
Height	NA cm STANDARD_DEVIATION NA • n=3 Participants	NA cm STANDARD_DEVIATION NA • n=3 Participants	NA cm STANDARD_DEVIATION NA • n=6 Participants
weight	NA kg STANDARD_DEVIATION NA • n=3 Participants	NA kg STANDARD_DEVIATION NA • n=3 Participants	NA kg STANDARD_DEVIATION NA • n=6 Participants
shirt collar neck size	NA cm STANDARD_DEVIATION NA • n=3 Participants	NA cm STANDARD_DEVIATION NA • n=3 Participants	NA cm STANDARD_DEVIATION NA • n=6 Participants
at what elevation does subject reside	NA METERS STANDARD_DEVIATION NA • n=3 Participants	NA METERS STANDARD_DEVIATION NA • n=3 Participants	NA METERS STANDARD_DEVIATION NA • n=6 Participants
ARISCAT score	NA units on a scale STANDARD_DEVIATION NA • n=3 Participants	NA units on a scale STANDARD_DEVIATION NA • n=3 Participants	NA units on a scale STANDARD_DEVIATION NA • n=6 Participants
POSPOM score	NA units on a scale STANDARD_DEVIATION NA • n=3 Participants	NA units on a scale STANDARD_DEVIATION NA • n=3 Participants	NA units on a scale STANDARD_DEVIATION NA • n=6 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: 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.

Respiratory Compromise markers are identified by continuous monitoring to determine the benefit of continuous monitoring on the general ward

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

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.

Outcome measures

Outcome data not reported

Adverse Events

Capnostream 20

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

PM1000N-RR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Capnostream 20 n=3 participants at risk Continuous monitoring of CO2 Capnostream 20 monitoring: Continuous monitoring on a general ward	PM1000N-RR n=3 participants at risk Continuous monitoring of SpO2 PM1000N-RR monitoring: Continuous monitoring on a general ward
Respiratory, thoracic and mediastinal disorders transfer back to intermediate care (IMC)	33.3% 1/3 • Number of events 1 • 7 months	0.00% 0/3 • 7 months

Additional Information

Geraldine Kelly

Medtronic

Phone: +353 879840223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place