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OpenTrials
Completed

NCT Number: NCT04355013

Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods

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

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Key information

Conditions

Temperature Change, Body Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IBSAL

Salamanca, 37007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Agreement Between Different Core Temperature Methods

    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

    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%.

Sponsors and collaborators

Lead sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2020
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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