Anesthesia, Capnography, Monitoring, Postoperative Care, Respiration Rate Detection, Surgery
Conditions
Keywords
capnography, Postoperative, surgery, anaesthesia, monitoring, respiration, novel equipment
Brief summary
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. 1. The primary outcome is to describe the correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream. 2. Secondary outcomes include 1. Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively. 2. Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively 3. The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2 4. Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3. 5. Comparison of oxygen flow by MARIE and the rotameter. 6. Comfort as reported by patient. 7. Usability as reported by nurse. 8. Reasons for premature termination of MARIE 9. Registration of technical problems, for example unexpected shut downs and blockage by mucus. 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.
Interventions
DEVICEMARIE
Portable capnoghraphy
Sponsors
Malin Jonsson Fagerlund
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult, ≥18 years of age 2. Elective surgery under general anesthesia 3. Planned for over night postoperative care
Exclusion criteria
1. Tracheostomy 2. Nasal obstruction 3. Rhino- or oral surgery 4. Not able to understand study information or signing consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream | From enrolment to discharge from the postoperative unit or maximum 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively. | From enrolment in the study until discharge from the postoperative unit or maximum 24 hours | 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 |
| Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively | From enrolment until discharge from the postoperative unit or maximum of 24 hours | Arterial PCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream will be measured repeatedly and thereafter correlated |
| The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2 | From enrolment until discharge from the postoperative unit or a maximum of 24 hours | EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2 will be collected simultaneously and repeatedly and thereafter investigated |
| Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3 | From the enrolment in the study and 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 will be measured simultaneously and thereafter compared and correlated |
| Comparison of oxygen flow by MARIE and the rotameter | From enrolment in the study until discharge from the postoperative unit or a maximum of 24 hours | Oxygen flow rate by MARIE and the rotameter will be documented repeatedly and simultaneously and thereafter compared and correlated |
| Comfort as reported by patient as VAS (0-10). | Three times/24 hours from admission to the postoperative unit until discharge from the postoperative unit or maximum 24 hours | 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 |
| Usability as reported by nurse as VAS (0-10). | From the time of enrolment until discharge from the postoperative unit of maximum 24 hours | The nurse will score the usability on a Visual Analogue Scale (VAS) from 0-10. 0=Very low usability, 10=very high usability |
| Reasons for premature termination of MARIE | From the enrolment to the discharge from the postoperative unit or a maximum of 24 hours | Report of reasons for premature termination |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORMalin Jonsson Fagerlund, Professor
Karolinska University Hospital & Karolinska Institutet
Outcome results
None listed