Temperature Change, Body
Conditions
Keywords
Core temperature, Cardiac surgery
Brief summary
Observational study to compare core temperatures obtained by 6 methods in patients undergoing cardiac surgery under cardiopulmonary bypass.
Detailed description
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.
Interventions
DEVICECore emperature monitoring
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
Sponsors
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Only patients requiring a pulmonary artery catheter were included.
Exclusion criteria
* Sepsis or previous fever. * Previous bladder catheter without termistor * Deep hypothermic circulatory arrest.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Different Core Temperature Methods | 24 temperature measures per patient recorded at 5-min intervals for each method and averaged using the Bland-Altman method for repeated measures | 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%. |
Countries
Spain
Participant flow
Recruitment details
Adult patients undergoing cardiac surgery using cardiopulmonary bypass and requiring hemodynamic monitoring by means of a pulmonary artery catheter.
Pre-assignment details
Exclusion criteria were sepsis or previous fever, presence of a previous standard urinary bladder catheter (without thermistor) inserted prior to surgery, moderate hypothermic cardiopulmonary bypass, or deep hypothermic circulatory arrest.
Participants by arm
| Arm | Count |
|---|---|
| Patients Undergoing CPB Cardiac Surgery. Adult patients undergoing cardiac surgery using cardiopulmonary bypass and requiring hemodynamic monitoring by means of a pulmonary artery catheter. | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Patients Undergoing CPB Cardiac Surgery. | — |
|---|---|---|
| Age, Continuous | 66 years | — |
| Height | 165 centimeters | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 0 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | — |
| Race (NIH/OMB) White | 48 Participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 31 Participants | — |
| Weight | 70 kilograms | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Outlet | Agreement Between Different Core Temperature Methods | 35.0 celsius degrees (mean difference) |
| Nasopharyngeal | Agreement Between Different Core Temperature Methods | 35.2 celsius degrees (mean difference) |
| Bladder | Agreement Between Different Core Temperature Methods | 35.6 celsius degrees (mean difference) |
| Tcore | Agreement Between Different Core Temperature Methods | 34.8 celsius degrees (mean difference) |
| Venous Inflow | Agreement Between Different Core Temperature Methods | 34.8 celsius degrees (mean difference) |
Comparison: Arterial outlet-nasopharyngeal temperatures95% CI: [-1.1, 0.77]
Comparison: Arterial-venous inflow temperatures95% CI: [-0.63, 0.95]Bland-Altman
Comparison: Arterial outlet-bladder95% CI: [-1.98, 0.74]Bland-Altman
Comparison: Arterial outlet- Tcore95% CI: [-1.38, 1.54]Bland-Altman
Comparison: Nasopharyngeal-venous inflow temperatures95% CI: [-0.73, 1.38]
Comparison: Nasopharyngeal-bladder temperatures95% CI: [-1.5, 0.59]
Comparison: Nasopharyngeal-Tcore temperatures95% CI: [-0.9, 1.39]