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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-ID 25-06-053097 | Registry Identifier | Swedish Medical Products Agency |
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Postoperative respiratory complications are common and sometimes hard to detect early. Desaturation is a late sign of reduced minute ventilation, especially if the patient is on supplemental oxygen, and measurement of arterial or endtidal CO2 will rapidly detect a reduction in minute ventilation. Capnography offers a non-invasive and continuous measure of end-tidal expiratory pressure of carbon dioxide (EtCO2). Capnography is not a standard in postoperative care but rather quite rare. In the present study we evaluate a novel portable capnography device, MARIE, in postoperative patients.
The primary outcome is to describe the correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream.
Secondary outcomes include
MARIE will be applied immediately after tracheal extubation after surgery. CO2 values from MARIE will be compared to EtCO2 and PaCO2 derived from capnography equipment routinely used in the hospital and blood gas analysis, at set intervals in the postoperative ward. Respiratory rate will be compared to our standard care monitors, ie Philips Intelli Vue X3, alongside manual counting. Rate of oxygen delivery, when applicable, will also be compared to the rotameter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MARIE | Experimental | Portable capnograph |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MARIE | Device | Portable capnoghraphy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream | End-tidal CO₂ (EtCO₂) measurements will be measured by MARIE (Oxlantic Medical AB) and Philips Intelli Vue X3 Microstream at several occasions and thereafter correlated | From enrolment to discharge from the postoperative unit or maximum 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively. | Measurement of arterial PCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream at the same time will be done repeatedly and thereafter correlated | From enrolment in the study until discharge from the postoperative unit or maximum 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malin Jonsson Fagerlund, Professor | Karolinska University Hospital & Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively | Arterial PCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream will be measured repeatedly and thereafter correlated | From enrolment until discharge from the postoperative unit or maximum of 24 hours |
| The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2 | EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2 will be collected simultaneously and repeatedly and thereafter investigated | From enrolment until discharge from the postoperative unit or a maximum of 24 hours |
| Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3 | Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3 will be measured simultaneously and thereafter compared and correlated | From the enrolment in the study and until discharge from the postoperative unit or a maximum of 24 hours |
| Comparison of oxygen flow by MARIE and the rotameter | Oxygen flow rate by MARIE and the rotameter will be documented repeatedly and simultaneously and thereafter compared and correlated | From enrolment in the study until discharge from the postoperative unit or a maximum of 24 hours |
| Comfort as reported by patient as VAS (0-10). | Comfort by the patient will be scored by the patient three times/24 hours on average Visual Analogue Scale from 1-10. 0= Worst comfort, 10= Comfortable | Three times/24 hours from admission to the postoperative unit until discharge from the postoperative unit or maximum 24 hours |
| Usability as reported by nurse as VAS (0-10). | The nurse will score the usability on a Visual Analogue Scale (VAS) from 0-10. 0=Very low usability, 10=very high usability | From the time of enrolment until discharge from the postoperative unit of maximum 24 hours |
| Reasons for premature termination of MARIE | Report of reasons for premature termination | From the enrolment to the discharge from the postoperative unit or a maximum of 24 hours |