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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core emperature monitoring | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 24 temperature measures per patient recorded at 5-min intervals for each method and averaged using the Bland-Altman method for repeated measures |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing cardiac surgery under cardiovascular bypass
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IBSAL | Salamanca | 37007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35133212 | Result | Sastre JA, Lopez T, Moreno-Rodriguez MA, Reta-Ajo L, Rubia-Martin MC, Diez-Castro R. Reliability of different body temperature measurement sites during normothermic cardiac surgery. Perfusion. 2023 Apr;38(3):580-590. doi: 10.1177/02676591211069918. Epub 2022 Feb 8. |
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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.
Adult patients undergoing cardiac surgery using cardiopulmonary bypass and requiring hemodynamic monitoring by means of a pulmonary artery catheter.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Undergoing CPB Cardiac Surgery. | Adult patients undergoing cardiac surgery using cardiopulmonary bypass and requiring hemodynamic monitoring by means of a pulmonary artery catheter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Undergoing CPB Cardiac Surgery. | Adult patients undergoing cardiac surgery using cardiopulmonary bypass and requiring hemodynamic monitoring by means of a pulmonary artery catheter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%. | Posted | Median | 95% Confidence Interval | celsius degrees (mean difference) | 24 temperature measures per patient recorded at 5-min intervals for each method and averaged using the Bland-Altman method for repeated measures |
|
No adverse effects were measured
It is an observational study comparing different methods of temperature monitoring in cardiac surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Adverse Effects Were Measured | No adverse effects were measured | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. José A. Sastre | University Hospital of Salamanca | +34923291100 | 55580 | jasastre@saludcastillayleon.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2016 | Mar 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| Height | Median | Inter-Quartile Range | centimeters |
|
Temperature in nasopharynx
| OG002 | Bladder | Temperature in bladder |
| OG003 | Tcore | Skin temperature measure with Tcore |
| OG004 | Venous Inflow | CPB venous inflow temperature |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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