Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods

Temperature Change, Body Clinical Trial

Official title:

Temperature Monitoring in Cardiac Surgery: Clinical Study of Agreement Between Different Measurement Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355013
• Other study ID #: CAUSA27/04/2016
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Body Temperature Changes
• Temperature Change, Body

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)