The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients

Not Applicable

Completed

• Conditions: Heart Diseases
• Interventions: Procedure: Cardiac output measurement synchronised at start of expiration; Procedure: Cardiac output measurement timed to instructed exhalation; Procedure: Cardiac output measurement at random to respiration

• Registration Number: NCT01944254
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

The intention of this study is to determine whether the precision of the measure of cardiac output can be optimized by conducting the measurement while the participant is instructed to exhale slowly. This will be compared to measurements done at random to respiration and timed with the participant's spontaneous expiration.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-07
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-17
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Every patient that receives a pulmonary artery catheter (PAC) related to elective cardiac surgeries,
• informed and written consent to participation in the study in accordance with the Helsinki declaration
• hemodynamic stability

Exclusion Criteria

• Hemodynamical instability
• atrial fibrillation
• tricuspid insufficiency ≥ grade 2
• hemodialysis or other conditions where extra volume load can be negative,
• lack of ability to give a written consent to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
timed with expiration start	Cardiac output measurement synchronised at start of expiration	Cardiac output measurement synchronised at start of expiration.
timed to instructed exhalation	Cardiac output measurement timed to instructed exhalation	Cardiac output measurement timed to instructed exhalation. The patient will receive instructions to exhale slowly using a peak expiratory flow (PEF)-flute and the cardiac output measurement will be started (i.e bolus given) at the start of expiration.
random to respiration	Cardiac output measurement at random to respiration	Cardiac output measurement at random to respiration

Primary Outcome Measures

Name	Time	Method
The observed variance amongst the cardiac output measures	1 hour	The measures will be obtained the first postoperative morning by pulmonary artery catheter thermodilution technique. In total 24 measurements will be done in each patient, i.e 8 measurements in each interventional series described later. The variance observed will create the foundation for calculating the precision of the measures.

Trial Locations

Locations (1)

Department of circulation and medical imaging, NTNU; 🇳🇴 Trondheim, Norway