An observational study in Temperature Change, Body, sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Observational
Observational study to compare core temperatures obtained by 6 methods in patients undergoing cardiac surgery under cardiopulmonary bypass.
This study compares the core temperatures obtained by means of different probes placed in nasopharinx, pulmonary artery, arterial outlet, venous inlet, bladder and forehead in patients undergoing cardiac surgery under cardiopulmonary bypass.
Patients undergoing cardiac surgery under cardiovascular bypass
Exclusion Criteria:
Monitoring core temperatures with probes placed in the arterial outlet and venous inlet of extracorporeal pump, pulmonary artery, bladder, nasopharinx and forehead using a doublé-sensor probe
Agreement Between Different Core Temperature Methods
Agreement between core temperatures obtained in arterial CPB output versus venous inlet of CPB, bladder, pulmonary artery, nasopharynx and forehead (Tcore). The measurements were compared between the different methods using the Bland-Altman method of repeated measures and expressed as mean difference (reference method-alternative method) plus CI95%.
Time frame: 24 temperature measures per patient recorded at 5-min intervals for each method and averaged using the Bland-Altman method for repeated measures
Adult patients undergoing cardiac surgery using cardiopulmonary bypass and requiring hemodynamic monitoring by means of a pulmonary artery catheter.
| Milestone | Patients Undergoing CPB Cardiac Surgery. |
|---|---|
| Started | 48 |
| Completed | 48 |
| Not completed | 0 |
Agreement between core temperatures obtained in arterial CPB output versus venous inlet of CPB, bladder, pulmonary artery, nasopharynx and forehead (Tcore). The measurements were compared between the different methods using the Bland-Altman method of repeated measures and expressed as mean difference (reference method-alternative method) plus CI95%.
| celsius degrees (mean difference) | Arterial Outlet | Nasopharyngeal | Bladder | Tcore | Venous Inflow |
|---|---|---|---|---|---|
| Agreement Between Different Core Temperature Methods | 35.0 (34.9 to 35.0) | 35.2 (35.1 to 35.3) | 35.6 (35.5 to 35.6) | 34.8 (34.7 to 35.0) | 34.8 (34.7 to 34.9) |
Collected over No adverse effects were measured. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Adverse Effects Were Measured | — | — | — |
| Age, Continuous(years) | Patients Undergoing CPB Cardiac Surgery. |
|---|---|
| Median | 66 (60 to 76) |
| Sex: Female, Male(Participants) | Patients Undergoing CPB Cardiac Surgery. |
|---|---|
| Female | 17 |
| Male | 31 |
| Race (NIH/OMB)(Participants) | Patients Undergoing CPB Cardiac Surgery. |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 48 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Race and Ethnicity Not Collected(Participants) | Patients Undergoing CPB Cardiac Surgery. |
|---|
| Weight(kilograms) | Patients Undergoing CPB Cardiac Surgery. |
|---|---|
| Median | 70 (64 to 82) |
| Height(centimeters) | Patients Undergoing CPB Cardiac Surgery. |
|---|---|
| Median | 165 (160 to 170) |
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Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León