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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04355013
Other study ID # CAUSA27/04/2016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 28, 2016
Est. completion date November 22, 2017

Study information

Verified date January 2021
Source Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational study to compare core temperatures obtained by 6 methods in patients undergoing cardiac surgery under cardiopulmonary bypass.


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.


Recruitment information / eligibility

Status Completed
Enrollment 304
Est. completion date November 22, 2017
Est. primary completion date November 22, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Core 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

Locations

Country Name City State
Spain IBSAL Salamanca

Sponsors (2)

Lead Sponsor Collaborator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León Instituto de Investigacio´n Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Agreement between different core temperature methods Agreement between core temperatures obtained in arterial output and venous inlet of CPB, bladder, pulmonary artery, nasopharinx and forehead (Tcore) 24 temperature measures per patient recorded at 5-min intervals during surgery (8 readings in the pre-CPB period, 8 during the CPB period and 8 aftr CPB period)
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