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Poor recruitment rate due to difficulties in identifying suitable patients
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capnostream 20 | Other | Continuous monitoring of CO2 |
|
| PM1000N-RR | Other | Continuous monitoring of SpO2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capnostream 20 monitoring | Behavioral | Continuous monitoring on a general ward |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Hoeft, MDPhD | Universitätsklinikum Bonn (AöR), D-53127 Bonn - Germany | Principal Investigator |
| Michael Sander, Dr.Med | Universitätsklinikum Gießen und Marburg (UKGM) , 20043 Marburg - Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Bonn | Bonn | D-53127 | Germany | |||
| Universitätsklinikum Gießen und Marburg |
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| ID | Title | Description |
|---|---|---|
| FG000 | Capnostream 20 | Continuous monitoring of CO2 Capnostream 20 monitoring: Continuous monitoring on a general ward |
| FG001 | PM1000N-RR | Continuous monitoring of SpO2 PM1000N-RR monitoring: Continuous monitoring on a general ward |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capnostream 20 | Continuous monitoring of CO2 Capnostream 20 monitoring: Continuous monitoring on a general ward |
| BG001 | PM1000N-RR | Continuous monitoring of SpO2 PM1000N-RR monitoring: Continuous monitoring on a general ward |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | 72 hours |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capnostream 20 | Continuous monitoring of CO2 Capnostream 20 monitoring: Continuous monitoring on a general ward |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| transfer back to intermediate care (IMC) | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment | AFTER PATIENT RETURNED FROM IMC TO NORMAL WARD, SHE BECAME WORSE WITH HER LUNGS. THE LETTER TO THE DR DESCRIBES POSTOPERATIVE PLEURAL EFFUSION ON BOTH SIDES. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geraldine Kelly | Medtronic | +353 879840223 | geraldine.kelly@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 19, 2019 | Dec 3, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2019 | Dec 3, 2020 | SAP_001.pdf |
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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.
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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.
| PM1000N-RR monitoring |
| Device |
Continuous monitoring on a general ward |
|
| Marburg |
| 20043 |
| Germany |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| weight | Mean | Standard Deviation | kg |
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| shirt collar neck size | Mean | Standard Deviation | cm |
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| at what elevation does subject reside | Mean | Standard Deviation | METERS |
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| ARISCAT score | ARISCAT Score is an accurate risk score for predicting high or intermediate risk for postoperative pulmonary complications in patients undergoing surgery, calculated based on preoperative data such as on patient's age, preoperative SpO2, respiratory infection, anemia, surgery type and duration. An ARISCAT score of ≥ 26 indicates high or intermediate risk for postoperative pulmonary complications. Low risk: <26, Intermediate risk: 26-44, High risk: ≥45 No theoretical minimum and maximum score exists; scores are calculated based on patient variables (listed above). | Mean | Standard Deviation | units on a scale |
|
| POSPOM score | POSPOM Score is an accurate risk score for predicting in-hospital mortality in patients undergoing surgery, calculated based on preoperative data such as on patient's age, planned surgery and presence of additional diseases or disorders. POSPOM <20: Average risk (less than 0.4% predicted risk) POSPOM=24: 3 times the average risk (1.2%) POSPOM=28: 10 times the average risk (4.2%) POSPOM=33: 40 times the average risk (16.5%) No theoretical minimum and maximum score exists as scores are calculated based on patient variables (listed above). | Mean | Standard Deviation | units on a scale |
|
|
| 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. | 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. | Posted | 72 hours |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | PM1000N-RR | Continuous monitoring of SpO2 PM1000N-RR monitoring: Continuous monitoring on a general ward | 0 | 3 | 0 | 3 | 0 | 3 |
|
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