Respiratory Complication
Conditions
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.
Interventions
BEHAVIORALCapnostream 20 monitoring
Continuous monitoring on a general ward
DEVICEPM1000N-RR monitoring
Continuous monitoring on a general ward
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Caregiver)
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantify the Incidence and Severity of Post-operative Respiratory Compromise Markers | 72 hours | Respiratory Compromise markers are identified by continuous monitoring to determine the benefit of continuous monitoring on the general ward |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate 2 Different Monitoring Devices | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capnostream 20 Continuous monitoring of CO2
Capnostream 20 monitoring: Continuous monitoring on a general ward | 3 |
| PM1000N-RR Continuous monitoring of SpO2
PM1000N-RR monitoring: Continuous monitoring on a general ward | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Capnostream 20 | PM1000N-RR | Total |
|---|---|---|---|
| Age, Customized | NA years | NA years | NA years |
| ARISCAT score | NA units on a scale | NA units on a scale | NA units on a scale |
| at what elevation does subject reside | NA METERS | NA METERS | NA METERS |
| Height | NA cm | NA cm | NA cm |
| POSPOM score | NA units on a scale | NA units on a scale | NA units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Germany | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
| shirt collar neck size | NA cm | NA cm | NA cm |
| weight | NA kg | NA kg | NA kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 1 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
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
Time frame: 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.
Secondary
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.
Time frame: 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.