Trials / Terminated
TerminatedNCT03571646
LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Medtronic - MITG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Capnostream 20 monitoring | Continuous monitoring on a general ward |
| DEVICE | PM1000N-RR monitoring | Continuous monitoring on a general ward |
Timeline
- Start date
- 2019-05-09
- Primary completion
- 2019-12-14
- Completion
- 2019-12-14
- First posted
- 2018-06-27
- Last updated
- 2021-03-08
- Results posted
- 2021-03-08
Locations
2 sites across 1 country: Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03571646. Inclusion in this directory is not an endorsement.