Karolinska University Hospital
Stockholm, 17176, Sweden
NCT Number: NCT07178236
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stockholm, 17176, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Portable capnoghraphy
Time frame: 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
Time frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the enrolment to the discharge from the postoperative unit or a maximum of 24 hours
Report of reasons for premature termination
Malin Jonsson Fagerlund
Other
Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Postoperative Patients - A Prospective Feasibility Study
Acronym: NOVOCAP-Postop
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