Study on the Repeatability of Cardiac Output Measurements Dependence of Temperature of Injectate

This study tests the reliability of thermodilution cardiac output measurements with pulmonary artery catheters in immediate connection with heart surgery. In accordance with our clinical practice, thermal indicator injections are synchronized with respiration. The impact on measurement repeatability of spontaneous vs artificial ventilation and the effect of the injectate temperature is tested.

The study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to be within 5 % of the "true" cardiac output in mechanically ventilated patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St Olav University Hospital

Trondheim, Norway

About this study

Bolus thermodilution cardiac output measurements by means of a pulmonary artery catheter have been a mainstay of monitoring critically ill patients for more than thirty years. Recent studies have questioned wether the traditional practice of averaging measurements from tree room temperature thermal indicator injections give sufficient precision.

This study tests the number of indicator injections necessary to be within 5 % of the "true" cardiac output (taken as the average of 16 injections) when the injection is synchronized with the respiration. The reliability of the thermodilution measurements are tested A) in sedated, artificially ventilated cardiac surgical patients and B) in the same patients when postoperatively awake and spontaneously breathing. We further compare the use of room temperature and iced thermal indicator injections.

The study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to achieve the desired precision in mechanically ventilated patients.

Only patients receiving a pulmonary artery catheter according our institution standard procedure of care will be included.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Cardiac surgical patients who receive a pulmonary artery catheter according to the institution clinical criteria -

Exclusion criteria

Acute cardiac surgery
Preoperative arrythmias

Treatment and study plan

Pulmonary Artery Catheter

Device

Four series of cardiac output measurements, each series consists of eight measurements using cold and eight measurements using tepid injectate. Randomized order of temperature at first series and crossover design.

Other names: Baxter

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

The Impact of Temperature of the Injectate on the Precision (Repeatability) of Cardiac Output Measurements Synchronized With the Respiration (the Temperature Study)

Important dates

Study start: 2006
Study completion: 2007
First posted: Apr 24, 2007
Registry last updated: Jul 18, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed